Oral FMT Options for Chronic Gut Issues with Dr. Jason Klop

Welcome to The Perfect Stool: Understanding and Healing the Gut Microbiome. This is your host, Lindsey Parsons, and today I'll be speaking with Dr. Jason Klop, CEO and founder of Novel Biome. Jason began his journey in the fecal microbiota transplant, or FMT, field in 2018 after a prospective patient who had an extensive history of antibiotic use urged him to find a solution to make FMT more accessible. A retired naturopathic doctor, Jason brings a unique blend of clinical expertise and entrepreneurial vision to NovelBiome. Under his leadership, the company focuses on delivering high-quality, clinically validated FMT products to doctors, clinics, and hospitals around the world, advancing gut health through safe, effective microbiome-based therapies. But before our conversation, if you haven't yet followed or subscribed to the show, be sure to do so. If you want to get transcripts of the podcast, pop over to my website, HighDesertHealthCoaching.com, and sign up for my newsletter. Newsletter. You'll also get my free ebooklet, Finding Your Root Cause Through Stool and Organic Acids Testing, when you sign up. And if you haven't yet done my quiz on which stool or functional medicine test would help you get to your root cause, you can find a link in the show notes and take that. Now on to the show. Welcome to the podcast, Jason. Thank you.

Excited to be here.

Yeah, so I had Shayna Cahill, your colleague, on a while back on episode 88, which published in January of 2023. So can you tell us how your work at Novel Biome has changed since then and about the new direction you've taken?

Wow. That sounds not too long ago and also a lifetime ago. Although I'm still grappling with the idea that it's 2025 still in my mind. I'm signing stuff, I write 2024 and then have to, you know, edit myself. But before we know it, we'll be in '26. But yeah, a lot has changed. A lot of good stuff, I would say. I spent many years treating patients, you know, starting back in early 2018 with FMT and did that until about mid-2023. And then in that period, we transitioned out of the direct-to-patient treatment model and instead now focus exclusively on supplying products to other clinics, hospitals, doctors, et cetera, around the world. The other big thing I would say that's changed is that we've gotten licensed by Health Canada. So we have now what's called a drug establishment license. And so we're considered now a GMP drug manufacturing facility. And in the world of FMT, it's, this is kind of a unique thing. We're the first in Canada to get this license particular to FMT and the inspectors and everyone else involved in the process was, this is very obviously a very unique product. And so we're really helping in some ways chart the course of FMT manufacturing in Canada.

Okay, cool. So what sparked your interest in FMT originally?

You know, my journey's been an interesting one. The origin story, so to speak, of FMT is that I, in 2017, I had a patient. So my background's as a naturopathic doctor. And when I started practicing and seeing patients, I just kind of glammed onto digestive health. That was an area that always sort of fascinated me. The microbiome was interesting at that time, 10+ years ago, it was sort of an up-and-coming area. In some ways. So I really decided this is the area or the lane that I want to, you know, get to learn more about. And so naturally, I attracted a lot of patients who had those particular issues. And frankly, the conventional medicine system doesn't really have a solution for a lot of these patients who fall out of the cracks from— they don't have nothing obvious, right? There's no cancer, there's no appendicitis, there's no, you know, infectious disease. There's no obvious things that you could find on a lab or a scan or an MRI. And so these patients kind of fall through the cracks and naturopathic medicine in many cases is a good solution for them because it takes the diet and the lifestyle and all the other potential factors into play. So anyways, in 2017, I had someone who was reaching out about being a prospective, they wanted to become a patient of mine. And at that time I'd always screen people to make sure like, we're a good fit. I think I can, you know, have some tools that potentially help you. But in the course of the call with this patient or this prospective patient, it was very clear they had literally done and tried everything. Typical person who really went through everything to try to find a way, including doing all the integrative functional stuff, all the holistic alternative, including all of the conventional Mayo Clinic, Cleveland Clinic, all of it. Her and her husband eventually got so desperate, they sold everything they owned. They bought an organic plot of land, built an environmentally sustainable, clean home, grew all of their own food. And despite all of these drastic changes, she was still struggling significantly.

With what condition?

Just chronic complex IBS, energy. Of course, all of it adds on to this, but the energy issues, fatigue issues, brain fog, I mean, you name the things that happen. There were probably some autoimmune conditions in there. I mean, it was a lot. And that's what happens when you go to all these different clinics is they just attach more diagnoses to it in hopes that that'll give access to some drug that will then improve some aspect of what she was going through. But anyways, towards the end of that call, I just said, look, like, I really don't feel like there's anything that I have to offer that's different or better or more innovative or whatever than all of the things you've already done and tried. But I think you should look into and consider FMT as a treatment option because her history included a lot of antibiotics and all of the things that we know damage the gut microbiome. And so at that point, you know, oh my gosh, Dr. Kloth, like, I would love to, I know all about this, but the only way for me to access is to go overseas and there's just no way that my health will allow me to travel. And so that was what started the journey in late 2017. And then in early 2018, I started treatment with patients using FMT and it's just sort of grown and expanded from there.

So did she end up doing it with you?

And yeah, this is the, this is the unfortunate part of the story. I wish I had a better ending. But no, I actually, it didn't take me very long. I probably spoke to her in about September, October and had everything lined up by January 2018 to accept patients. And I tried calling, I tried emailing and never got ahold of her. She was older. And I think given her health, my assumption is probably she succumbed to her illness.

Oh, wow.

Because she was pretty dedicated to the idea of doing it, but, uh, you know, a couple months. That's unfortunately the nature of things in some of these cases. So unfortunately there's no pretty end to that story, but the good news is, is she helped propel what is now, you know, our mission of, of expanding access to FMT globally.

Yeah. And it just makes me think about the fact that, and I often see people who say, I've had digestive issues since I was a child and they're in their forties, fifties, sixties, or it's been 20 years since I've had chronic diarrhea. And I'm just thinking, how do you live with this stuff for that long without without like looking further. I mean, the internet's been around now for a while.

Yeah. You can't plead ignorance.

No. Like there's stuff out there. I don't know how you put up, I mean, maybe they just got in a financial place where they could go beyond their insurance and what, what's offered there, but yeah. Don't wait, people. Yeah.

I mean, I think it's a combination of things though, right? Like for some people it's, it is like, you know, they go, they, they just, they only think conventionally. And so their doctor just says, hey, there's nothing you can do. And they just kind of accept it as just this is how I'm going to live. I mean, it still sort of shocks me, but recently I was in somewhere in the South in the US and I had an Uber driver and she, you know, as soon as someone finds out you're anyway tangential to medicine, they're happy to tell you their whole, you know, medical history. And so she's telling me about her diabetes and, you know, I won't go into the whole list, but I was just telling her, you know, did your doctor ever tell you that, you know, maybe walking will help or by controlling your eating, you'll be able to control your blood sugars and no, none of that. Like she just was totally unaware of all of those things. Maybe like blissfully ignorant. I don't know. But she was like, no, I drink Diet Coke instead of the regular Coke. And I said, well, if you stop doing that and drank water and started walking between your rides, when you're waiting for the next trip, you probably actually might be able to get off some of this diabetes medication. But so I don't know, there's that, but then there's the other part of people are trying a lot of stuff or what they know. And, uh, Yeah.

Yeah. So what different forms of FMT are available nowadays?

Yeah, I mean, I think there's a, a big shift to oral FMT and that's definitely something we've seen and, and also helped pioneer in the sense of the oral powder that we have that we developed for pediatrics and have gotten patented in the US and, and now getting patents in other countries around the world. I used to, when I started, I was just doing rectal FMT via enemas. Back in 2018. And, uh, and that worked for some people, but not all. And, and so once we started, I wanna say like 2019 and, and sort of when you look at the research, 2019, '20 is when you started to see more and more studies using oral FMT. And so from my experience clinically, we just began seeing much better outcomes when we were treating orally.

Hmm. Interesting.

And it's not in a pill, it's just a powder, so it's We do have oral capsules as well.

Oh, you have oral caps—

So there's oral capsules and oral powder, but the oral powder is primarily for the pediatrics who can't swallow a capsule. The advantage to the oral capsule is that it's double encapsulated and enteric coated, so it gets past the stomach acid. So where possible, we're always encouraging people to use the oral capsules, but in a pediatric population, especially in the context of autism, that might not be possible for some kids, even if they're already a teenager, they just lack the, you know, the sense motor skills in order to be able to swallow.

Yeah. So given people are taking it in a powder, obviously, or even the capsule format, this is not the old-fashioned crapsool. This is like an actual, like purified powder such that it doesn't taste like it came from fecal matter.

Yeah. I mean, in the context of the oral powder, I mean, it's sub— literally substantially colorless, odorless, and tasteless. So when you mix it with about 5 ounces of water, which is what we like, a cup of water, it's indistinguishable. And we had another, a third-party company do a freeway test with real humans who were trying to distinguish— this is the company, it's what they do, it's their like business— to see if they could distinguish a taste or a smell or an odor, and they can't. And so, yeah, I mean, you're right. It's changed from just like mixing some poop up with saline or water and squirting it into a capsule to really just concentrating for the microbiome, which is a part of the stool so that we're not adding a whole bunch of extra waste products that don't have any obvious medicinal value. I recently spoke to family and they were using, you know, it was like a mother-son and they were using her stool as a DIY FMT. And I was just saying like, the comparison is probably, and it may be way more, but like one DIY capsule, you may require like 15 or 20 of those to get one of our purified product, maybe way more. I don't know. You know, it's like you'd have to do all the, the science stuff to be confident about it. But there's a lot of fiber in stool, right? I mean, that's what takes up a lot of volume of the stool. Okay. So when you screen all that off and you concentrate even further, you remove all of that and you're left with all of the active parts of the microbiome that will have real medicinal value.

And how are you getting anaerobic bacteria into a powder where they're not hitting oxygen?

Yeah, they're gonna be exposed to oxygen and we do lose some anaerobic bacteria. I mean, that is the nature of it. So as you, as you do more processing compared to like a fresh FMT where you have the donor sitting right here and you have the patient sitting right here and donor goes poop and go, you know, you squirt it straight into the patient, like there's gonna be more of the complete set of microbes there. But when you do more of the processing, each of these subsequent processing steps will result in some loss of the active forms. But with that said, we still do anaerobic testing of our finished products and as a metric of like what level of anaerobic microbes, cuz we could, you know, we could test for the aerobic ones and there'd be lots, but the anaerobic ones we're also testing in as part of our finished product release and they're still there in very high levels. So it's a part of our manufacturing process. It's not all done anaerobically cuz that's, almost impossible, especially at some larger scale that we're doing. But yeah, you're going to lose some. But the reality is, you know, we still don't, as a medical scientific community, know what precisely is responsible for the benefits of FMT. You know, it's not just anaerobic, it's not just aerobic, it's not just— it's all of it. It's everything combined. And I think the metabolites, the like spinoff of what the microbes are producing, Right. The postbiotics potentially has as much or more impact on the outcomes than the actual microbes themselves, although likely it's the whole thing. And I kind of, you know, the explanation that I like to think of this is it's like, it's like the Amazon jungle, you know, it's the whole living biosphere. It's not just the trees, right? Like, yeah, the trees take up a lot of what you see, but with, if it was just trees, you're not going to get the same outcome. And that's probably partly why we don't see the benefits with probiotics. That we do with FMT.

And is each end product that someone is getting from just one donor, or is there a combining of donors?

No, we are, we're not combining anything in the sense of like, because we're a GMP drug manufacturing lab, like everything is controlled. There's no crossover of one donor to the other. We operate clean rooms, and between production, everything is cleaned and there's environmental monitoring. And it's, it's a very exhaustive process. With that said, as part of a treatment regimen, yeah, you could get access to more than one donor product to try to increase the diversity of the microbes that you're getting instead of just from one donor, from two or three donors for the course of the protocol.

So where could someone access your products outside of the US where FMT isn't limited to C. diff? Are there clinics that use your products in other countries? For other purposes?

Yeah. You know, what works well is if you have a healthcare provider and, and they're open to some of these alternative integrative, more forward-thinking treatments, have them reach out and work with us. Like just this morning, I spoke with a doctor from Pasadena, California, and he learned about us through a treat— a patient. And so that's like an avenue to understand to, to get access versus you reach out to us, you know, we're not gonna sell it to a patient directly, but if you have a doctor who's open to it, then we could work something out with them. Otherwise, it is possible to reach out to us and depending where they are in the world, we may have a partner there, we may not. So it would just really depend.

So what you're saying is that sort of in the way that doctors use other drugs off-label, that a doctor could in theory use your FMT product off-label for say ulcerative colitis or something else? Yeah.

I mean, the FDA has some clear but unclear guidance on, on FMT in the US. I mean, I think it's intentionally unclear. And so in some ways it's, doctors have to, it's up to their own interpretation in some respects, but, but there are some avenues of off-label prescribing has been happening since the dawn of time, since the dawn of prescriptions, off-label prescribing's been happening. But also there are some, obvious paths, like going with an IND and sympathetic use, I forget the name of it, cases where there's like really no other options, they can get access to it. So there are some very clearly defined paths, but then there are some like, maybe it's okay paths. So ultimately it just depends on the patient, what their condition is and some other variables.

Yeah. I mean, I know that like, it's relatively easy, relatively, it's still expensive, but you can access FMT in the UK, you can access it in Australia. And you for a while were operating outta Mexico. Is there any place, you know, I, and I think there's a Bahamas clinic for, are there any places that have come up closer to here or less expensive than those others that are using your product? Yeah.

Yeah. We have lots of doctors, a whole network that, that use our products in, in the US.

Yeah. Yeah. For, for other conditions.

It depends what I, we're not controlling how, you know, Right, right, right. Exactly. They're using it for, but yeah.

Okay. So what conditions do you think FMT is most promising for other than C. diff?

Yeah. The C. diff is an obvious one.

Yeah. Yeah.

I mean, the research is just exploding as far as the different conditions that are being included under the banner of ways in which FMT is showing benefit or progress. The obvious ones are of course, like the GI ones, IBS, IBD. So anything that's like obviously GI related. Diabetes is an obvious candidate, but then we're seeing a lot of great things in neurological diseases where, whether it's autism, which I told you we treated a lot of, Parkinson's, dementia, those types of things are showing a lot of progress. And then I think the area of cancer treatment is, is really fascinating where FMT is actually improving the benefits, like where a drug— a patient was not responding to the drug, they do FMT, and then they start responding again. So I think that's really exciting. Literally, if you go on PubMed and you search, pick a cancer, any cancer, pancreatic cancer and the microbiome, like every cancer, and I've done this before just out of my own personal curiosity, they all have studies that are linking it in some ways to the microbiome, you know, whether it's like cause or correlation. I mean, it's kind of hard to distinguish, but all of this stuff traces back to the microbiome in some way. And so it is fairly intuitive to think that if you improve your gut microbiome, you're going to better be able to utilize the drugs, the nutrition or supplements or whatever you're using, you're going to have a better effect, more durable effect. And I think the reality and probably what we'll see more and more is the synergistic effect of a microbiome-based therapeutic with other interventions, stem cells being another obvious one where there's some pretty interesting research around graft versus host disease. And the improvement of the microbiome through microbiome therapeutics. So yeah, I think there's, there's a lot of synergistic things where FMT combined with some other treatment will all combined get a better positive benefit. And then there's cases where patients aren't responding and they could respond if their microbiome was in a better, healthier place. And there's a whole nother avenue which is like, you know, the anti-aging longevity biohacking. I mean, I think why we die is our microbiome. I mean, it's like if our microbiome's not healthy, we're getting more inflammation, more inflammation leads to more disease. And you know, the progression just keeps going from there.

So, hey, this is Lindsey here, just letting you know that if you're tired of dealing with digestive issues like bloating, indigestion, soft stool, diarrhea, constipation, reflux, IBS, IBD, or the numerous health conditions that come about when your gut is off, like brain fog, weight gain, UTIs, fatigue, mental health issues, or complex conditions like fibromyalgia and ME/CFS, that's my specialty. With my 3 or 5 session gut health coaching packages, we'll discuss different stool and functional medicine tests to find out the root cause of your symptoms. I'll interpret the results and provide clear explanations, empowering you to make informed choices for your gut and overall health. And together we'll develop a customized action plan based on your test results so you can find relief and regain your health and vitality. I come from a functional medicine perspective, trying to incorporate the latest peer-reviewed research and educating you on protocols used by functional medicine practitioners, but devoting lots of time and support to my clients the way a doctor simply can't. If you're interested in a 3 or 5 session coaching package, you can sign up for complimentary 30-minute breakthrough session, or if you can only afford one appointment at a time, you can book an initial 60-minute consultation. Links for those are in the show notes. Now back to the show. So what kind of clinical trials are they running these days using FMT? Like what's, what's the, the newest?

You name it. I mean, it's across all kinds of areas. You know, I think the cancer one is a newer, more interesting area that's up and coming. Schizophrenia, bipolar. I've seen some pretty fascinating stuff. You know, they keep going with like the IBD, ulcerative colitis, Crohn's, autism. I mean, a lot of areas are just continually building on the established knowledge, but yeah, it's kind of across the board. There's lots. Yeah.

There's, yeah. Now I remember what I was gonna say. So when I, about, gosh, 3 years, 4 years ago, I don't know, I started the podcast in 2018, so now probably longer than that. I interviewed someone who was involved with the cancer research and he was talking about how FMT was making immunotherapy more effective. Great interview. Did not record.

No. Oh no.

Like I did not record the whole interview. So I approached him about re-recording. He just didn't even respond. I don't blame him at all. But anyway, it is that kind of tough though. You have a friend, they're diagnosed with cancer and you're just like, you ought to get an FMT. I mean, it's like if their doctor's not telling them about it, they're gonna be like, you crazy. Yeah.

I mean, I don't know. I, I see obviously a different part of this where people, you know, come into this space being relatively informed. I think when we move past poor branding of like capsules and things like that, like it literally looks no different than a probiotic. Like the concept here is not that extreme. It's not, it doesn't taste like anything. It doesn't smell like anything. This is a pretty straightforward thing. I mean, but, but yeah, I mean, some people are just gonna be totally turned off by it, but at the same time, like you're dying from cancer. I mean, you know, take your pick.

Yeah. I guess it's a different beast when you're talking about, yeah, like a colorless flavorless powder versus having to find a donor and yeah, if you can actually get access. I mean, I think that's the big problem is that there's probably very few doctors who are going to go outta their way to get you access to something they've never used or barely heard of. So what are the typical protocols for FMT in clinical trials regarding like using antibiotics beforehand and the duration and diet and all that?

Yeah, this is a great area. I mean, it's evolving a lot. As I mentioned previously, it used to be that it was typically just rectal delivery, whether it was like colonoscopy or enemas and a very short protocols. And that was always my issue with what was happening in science what I seen clinically was like short protocols just aren't working. Prior to Dr. Adams' work from Arizona State University on, on FMT for autism using a longer protocol, about 8 weeks, it was like the assumption was generally FMT doesn't work in the autism community. It doesn't, it just doesn't have a benefit because the protocol is way too short. And so C. diff was the first obvious indication that this worked swimmingly. It worked amazingly. And so then the natural proclivity is to say, well, it worked this way for C. diff, so let's take the same protocol and use it in MS or IBD or—

And, and C. diff, it was one shot, right? I mean, it was just— Yeah.

You know, one treatment, one, one enema, a couple capsules, one enema, one colonoscopy, and like 80, 90% of people are getting complete resolution. But the issue is that these, like C. diff is a very acute condition and, and people haven't been dealing with C. diff for years or decades of their lives. And so their microbiome is probably more pliable. You know, it could shift quickly and shifted quickly to C. diff. You could probably shift it quickly out of C. diff with the right input. And so that was the issue broadly, was the, the research was just using the same treatment protocols as developed for C. diff as they were in more of these chronic complex illnesses. And in some cases it was like,, you know, surprisingly seeing the benefit, but it wasn't that impressive. And so then, you know, just kind of get lost. Ah, it doesn't really work for this condition. And then until later, and now sort of 2019, 2020, when you look at the protocols, they're definitely more extended. They're treating over a longer period of time. And that's an option with oral capsules because with an oral capsule, you can treat over an extended period of time. You can't keep repeating colonoscopies. But you can keep repeating an oral capsule. So the protocols really vary. I mean, yes, predominantly treating with antibiotics pre-FMT is pretty much standard of care. I would say now all of the research when you—

Like vancomycin or?

Yeah, vancomycin is a common one. I mean, different, you know, depending on the country and whatever else is going on, they might use something else, but vancomycin is common. I'm a huge advocate of using antifungals as a part of the pretreatment. If there is mold, Clearing up the mold, I think, is another fungal thing that can prevent or restrict or limit engraftment of the new microbes. So, so yeah, I think the pretreatment part is pretty well established other than, you know, the fungal part and mold part that I mentioned, that's not typically considered. But then, then the, the start of the treatment is usually some combination of like a loading dose followed by a maintenance dose, which is what our approach was. But we're seeing all kinds of stuff where they'll be like, 12 capsules a day for 5 days, followed by like 12 capsules a week for, you know, 6 weeks, or like there's tons of different approaches and they're all interesting in their own ways. I think they all just include some acknowledgement that like having a higher dose over some repeated amount of time has some benefits. I think our goal, because the treatment is fairly expensive, is trying to find out like what is the minimum amount that you might need to get like a long-term benefit. And so I think that's being considered more broadly is like, okay, what, what can we do to get a limited amount of product just to go the furthest from a patient improvement standpoint? And so in, in C. diff, for example, there's some products that have been approved on the market and they're like 12 capsules, you know? So in that context, for a lot of people that's working. So if you can use 12 capsules, go with 12 instead of 25 or 30 or whatever the number might otherwise be. So I think in a lot of cases we're still figuring that out. But the reality is, is there's a lot of individual differences with patients. And so I think a lot of it is just you need to start treatment, you need to see how you're responding. And ideally your doctor is tracking with validated measures and/or combination of validated measures for symptoms and some sort of urine microbiome or stool microbiome or just diagnostic panels to understand what metabolites are shifting. So seeing how you're responding and moving along and then using that as the guide to determine how long you may need to treat.

Okay. So what criteria do you use for donor selection? Are you getting into the weeds of like what the stool looks like by view, whether there's butyrate producers providing what's missing in the microbiome of the intended recipient?

Yeah, we get really far into the weeds. I mean, we meet the, like, very, the, the standards that any jurisdiction that we sell product into sets. Health Canada is the obvious one that we have to meet because we're regulated and licensed by Health Canada, but that includes all the obvious infectious diseases and, and, and standards for donor screening. But we go above and beyond in the sense that we select for younger donors, 30 or under. We're, we're really queuing and quizzing to make sure that the diet is really good. They're physically fit and active. We look at their, their immediate family medical history and ensure there's no early onset of specific diseases that have some microbiome link, whether that be like psychiatric disorders or early onset of cancers or other things like that. So we look at that and, and use that as a, as a, another layer to determine if someone's gonna be potentially a donor that we could accept into our program. We accept about 1% of people who apply. So it's very stringent. And then of course they do, like I mentioned, all the stool, urine, blood testing to, to screen for anything pathogenic where it Daily, there's questionnaires that they're completing. And as a part of our quality department, we're evaluating every stool that comes into the lab to determine that it meets the criteria, which would include that it's an appropriate range in the Bristol stool chart. So like if there was blood or mucus or diarrhea, like totally discarded. So yeah, there's a lot of checks and balances that come into play before someone even becomes a donor. And then once they are an active donor, we're continuing to evaluate and monitor and make sure that they're not sick or have a cold or got a tattoo or some travel out, you know, abnormal. Like there's a lot of factors that go into that.

Yeah.

To your other point of, don't you kind of reference donor-patient matching? That is something we're working on to try to establish some model. To date, it doesn't exist. We acknowledge broadly in the medical community, like there is something there, but it's not yet been determined like what is what are the features that you could use to say, okay, yeah, this person's a match for this person. So I think that's the future of FMT and we're playing a role in developing that. But by far, you know, we're not on like an established science with that. It's, it's more we're building and learning as we go. But I think that will fine-tune as well the improvements that we can see. And ideally, it'd be nice to have a test to say you're likely to be a responder and you're not likely to be a responder. Instead of having someone have to go through this to find out, what if we could identify, you know, with, with some level of certainty, you know, hopefully a high level of certainty, whether or not it's going to work for someone. And then if so, who would be the ideal donor for them would be another factor. So yeah, I think we'll get there eventually. I think that's the future of, of FMT is more precision.

Seems like AI would be useful in this respect.

100%. Yes. Yes, absolutely.

Yeah. So are you looking at the butyrate producers? 'Cause I mean, the more I, I work in this field, the more I think it's all about the butyrate producer. Well, it's all about the short-chain fatty acid producers. Let's put it that way. That, that's, that's the hinge on which good gut health is turning.

Yeah. I mean, I, I think you're probably right, but you may be completely off base or we may be completely off base in thinking that. I mean, I agree. I think all of the butyrate you know, the production of these short-chain fatty acids that can moderate the inflammation and allow for the healing of the leaky gut and all of the other downstream things that come with that is a very plausible explanation as to why this works. But at the same time, I don't think it's any one of those things. I think it's a combination of like multiple things that when combined all have that effect. So if you just took out butyrate production, there's still going to be other benefits that are happening, but I do agree with you. I think that's a key piece. But yeah, I mean, having butyrate-producing bacteria would be a part of all of the things that were not like specifically screening for butyrate-producing bacteria in the stool specifically, but that's what would allow this 1% of people who even become a donor. They must have that in order to have health, right? I mean, you couldn't have good health without having a robust microbiome, which would include these butyrate-producing species.

Yeah. And of course that being what antibiotics tend to wipe out. So yeah. What is the criteria about like use of antibiotics for your donors?

Yeah, we have a lot of donors that have no lifetime history of antibiotic use, which is our, of course, preference, but not all. We have a limit on how many uses of antibiotics they can have. And I, I, I'm not like in the weeds on the donor screening, but a few lifetime uses is acceptable. I think the average is like, it's been minimum several years before they even had any antibiotic. And so, yeah, but you're right. I mean, having overuse of antibiotics would absolutely wipe that out.

Yeah.

And we select away from that.

Yeah. As a mother, I'm so proud that like my one son, the only antibiotics he ever had were when he was a baby. We adopted him, so it was before we got him and It's, they handed us him, right, with antibiotics and said, give this to him. And he like vomited every time we gave it to him. We're like, this is done. He's got a cold. We don't need to be giving him antibiotics for a cold. And then the other one, the only time as far as I can recall that he's ever had antibiotics was when he has, you know, one, one or two doses was when his wisdom teeth were removed. So I don't know how I was so lucky to not ever have to give my kids antibiotics, but I was.

Well, I mean, I, I, I mean, it's, it's hard honestly, like like if you just take your child to the doctor predominantly, most of the time they're going to be suggested an antibiotic and that's shifting. But at the same time, again, this is sort of the issue with the conventional insurance model is that the onus goes on to the doctor, the responsibility of their malpractice insurance. Like if they were to say, oh, we think it's just a viral infection, like just leave it, watch them, monitor them, make sure they're drinking enough and getting enough sleep and whatever the things are that you might suggest. If that patient happened to have something that was pathogenic, bacterial in nature, and they didn't prescribe an antibiotic, they're on the hook. And so in a lot of cases, they're just saying, I'm not going to take the risk. I'm going to prescribe it anyways. And so it is a problem, but antibiotic resistance is a huge, huge issue. And the WHO is predicting that by about 2050, antibiotic resistance will be a bigger killer than cancer is today. And so it is a huge, huge problem. Wow. And some people are aware of it, but it's still not, I don't think, getting the urgency and attention that it deserves. And FMT happens to be a player in antibiotic resistance like it is for C. diff, but there's a whole lot other, you know, a whole lot more other nastier things that could come along that could wipe way more people out than we're currently seeing. So I think we need to, personally, I think we still need to really do a lot of public health around reducing the overuse of antibiotics. At the same time, I'm hopeful that with AI and all these other technologies, we'll find more innovative antibiotics that are much more precise. And there's, you know, there's CRISPR therapies, there's all these things that are coming. But can't just rely on optimism. We need to be practical and try to minimize the overuse of antibiotics. So thank you for doing your part with your own kids. I'm doing the same.

Yeah. Well, yeah, I'm probably doing a little bit more as we— through my podcast. But I, I have found that the people who find me— I mean, it's rare that I find someone who's like, oh, I wanna take antibiotics. I mean, maybe Rifaximin, right? Cuz that's kind of a different class of antibiotic. And I think the, at least I've heard from Mark Pimentel's most recent webinars that their studies are saying it's just attacking the, the cause of SIBO, the E. coli, the Klebsiella. It's not knocking out the beneficial microbes. It's helping those come back because it's getting rid of the overgrowths. But you know, that being said, I, I, My other question related to this was, am I being, when I think about antibiotic resistance, am I being naive when I think, oh, that won't happen to me because I'll just take herbal antimicrobials that are not resistant?

Yes. Except that like in these more severe cases, an herbal antimicrobial is not gonna, currently wouldn't knock out C. diff, and that's an antibiotic-resistant bug. So, you know, you might have some safety there, but No, I don't, I don't, I don't think you can be that optimistic now.

Okay. Yeah. But then there's also phages. That's another one.

Yeah. And that's another theory as to why FMT is having an effect too, is the potential role of phages. But no, I think, I think the situation is more dire.

Really? Okay.

Yeah. And I'm like a hopeless delusional optimist, but I think in this context, we do need to take this much more seriously than we are. And it's a combination of overuse, but also over cleanliness. Like, the more you clean something— and in hospitals this is happening all the time, it's like a necessary part of trying to prevent the spread— but the more that you try to kill something, and the few that survive, they're, they're always evolving, right? They're always evolving to become more evasive against the things that are killing them, just like everything else that exists that's alive. We're all trying to evolve to become more resistant to the threats that are around us. And so these antibiotic-resistant bugs are doing the very same thing. They're trying to survive. They're all after the same purpose, life. Even if it's at the detriment to the host.

Yeah. So I had Christian John Lilas from the Peggy Lilas Foundation on episode 152 of the show, and he mentioned two products that are available now on the market instead of traditional FMT, the Vowsten Ribbiota. Can you tell me more about those? Do you have unspecified gut health issues and haven't gotten tested yet, or diagnosed SIBO, IBS, IBD, or Candida? My newest supplement, Serum Bovine Immunoglobulin, or SBI powder, may be the perfect thing to try. In a randomized double-blind placebo-controlled study of adults with IBS-D, GI symptoms including loose stools, hard stools, flatulence, and incomplete evacuation were significantly improved with a 5-gram-a-day dose of SBIs after 6 weeks, and abdominal pain, bloating, and urgency were also significantly decreased after 6 weeks of use at a dose of 10 grams a day of SBI powder. It's basically the immune system of a cow derived from plasma and made into a powder, so it binds and neutralizes a wide array of pathogenic bacteria and fungi and carries them out with your stool without hurting your beneficial microbes like antibiotics or even strong antimicrobial herbs will. It's also been shown to decrease intestinal permeability, decrease fat in the stool, increase the absorption and utilization of nutrients, and increase lean body mass. So give it a try today at perfectstool.com where you can also find my supplement Tributrin-Mix, which helps solidify stool and slow down motility for people with diarrhea or loose stool.

Well, those are basically traditional FMT. I mean, Rebiota is FMT, it's a rectal enema, and then Voust is not the typical, what you would think of FMT. It's more of a, more of the phages approach. So basically they're treating it with alcohol, killing almost everything except some of the phages. And that's what they're doing.

Oh, okay. I didn't realize that. Okay. So they're not essentially the same thing that you're doing. What you're doing is—

No. Well, Rebiota is fairly similar in the context of their— it's live, their biotherapeutic FMT, full microbiome, but it's only the rectal delivery and it's intended for C. diff. Although I know docs who are using it for oncology and all kinds of other interesting areas, which is pretty exciting. And then Voust is very different. It's FMT-esque, but like I said, it's, they're basically killing everything except some of these phages.

Interesting. So are you gonna give your product a name? So it's like not just FMT, like, I don't know.

Well, we're, we're not going down the, the whole, at this point. Drug approval process. I mean, that costs $100 million or something. Not quite in the budget. But yeah, I, I, I mean, our goal is really to try to support more research and get our product to clinical trials and all of those things starting here in Canada. In Canada, it's, the FMNT regulations are a little different than the US and other places. But yeah, that, who knows, that might be in the cart eventually.

Yeah. So how many donors do you actually have?

That I don't know, actually. I, it's, it's, this is common. You might, you might appreciate this and some might, the listeners. When we got licensing, I was involved in more aspects of what we do, including donor screening. You know, my background as a naturopathic doctor, I got a pretty good sense of what makes a good donor and we follow all the guidance. But even that I'm not able to be involved in and we have a medical doctor on our staff who does all of the donor screening and requisitions all of the labs and all the things. But anyways, The inspectors came here and they said, okay, what's the roles? And, you know, we had to org chart and all the things. And so they said, well, you can't be involved in any of those things. And I said, okay, well, what, what should I be doing? And they said executive stuff. So that's basically what I do, executive stuff. I do know we're, we're screening a lot of new Delvers and we're trying to meet ever-increasing demand. So I would say we're probably in the 5 to 10 mark right now, but by the end of the year, we may be in the 15 to 20 mark.

And how do you recruit people?

Through a lot of different ways, social media, advertising, local online newspapers, flyers, all sorts of different ways.

And where are you located?

We're in the Fraser Valley. So Chilliwack, which is close to Vancouver in Canada.

Okay. So there's a decent population to recruit from. Yeah. Yeah.

I mean, there's a couple million people. Take a big enough web. We have a driver who's literally just driving around all the time, picking samples up.

Oh, okay. So they don't have to come to the lab, they can get pickup at home.

Yeah, no, correct. Yeah. We have a fridge and the driver's got temperature controlled and— Ah, that probably makes it a lot more, you know, it's all chain of custody, the whole thing. Yeah. Very— Yeah.

So what do you reimburse somebody for a donation?

$25 per, and we have other perks and things that are included.

Okay, cool.

You know anybody who's, if you're listening and you happen to be in the living in Vancouver.

Yeah. My listeners are not the kind of people you want donations from. They start people with gut health issues.

Maybe not.

Maybe their spouses.

Well, they might know somebody. You never know. Right. Everybody knows somebody who knows somebody.

Yeah. They might know someone.

Yeah.

So if someone wanted to preserve their own stool in case of like needing it later to reintroduce it. Could they just store it in the freezer or what would be the best way to preserve it?

Oh, this is a great question. So I was really excited a few years ago and I was like, we need to launch this service. We need to be able to bank our own microbiome, have an autologous option for FMT. And I still think it's very exciting. And we actually have someone now who's very interested in partnering with us. They're a player in the, in the microbiome testing space in the US. And so we're kind of in preliminary discussions, but that we used to have that as like an optional service that people could do is like bank their own microbiome. And so I think, I think our website was like personalbiomebank.com or something. It still exists, but we just, among the whole bunch of initiatives, it was not one we really pushed. And frankly, there's a lot of education that goes into it. And a lot of the opposition was like, well, I'm just not quite healthy enough. Like, I want to do this, this, and this, and then I'll do it. The people that wanted it were like, I'm getting a surgery tomorrow and I want to bank it today. And it's like, sorry, like we can't get your stool and not in a timely manner in order to be able to do this. So I do think it's a huge opportunity. I think it's, it would be very exciting. I think the bigger opportunity is really in pediatrics because kids get a lot of, those are the ones who get the most drugs prescribed. So I think that's probably the market who would take this on more significantly than say like the average adult who hasn't been on an antibiotic in 10 or 15 or whatever years. But yeah, storing it in your own freezer, unfortunately you're gonna lose the bacteria pretty quickly because they lyse with freezing. They like explode. And so that's why you would need to add some kind of a cryopreservant to try to protect them from the freezing process. So like a glycerol, a trehalose, skim milk, something to try to protect them. But yeah, unfortunately it's not— there's no great way to do it, but that would be better than nothing, I suppose. But ideally there was like a convenient service like we imagined that existed that would allow you to bank your own microbiome and then just update it every once in a while. So I think that's— I think that's a huge opportunity that will exist in the future. And who knows, maybe we'll be playing a role in developing that. If there's anybody who's a player and wants to get involved, reach out. We're happy to have more people in space.

Well, if they could have their microbiome put into capsules in the purified form, how long would those last?

Well, that, and that's the opportunity is that that's what we developed was like, we'll take your stool, we'll store it, and when you need it, we'll encapsulate it and ship it to you. So that was our whole concept was, yeah, that it could be stored much longer if you had a cryopreservant, it was in a negative 80 or even cooler environment. And then you take it out to process it later into capsules if there was a, there was a need for it. So yeah, we, we sort of worked out a lot of those logistics, but then, you know, other priorities took hold and there wasn't a ton of obvious demand at the time.

So long and short, better to keep it in the frozen form than to process it. So how long does an actual processed pill of FMT last? 2 years?

I mean, we put a 2-year expiry from the date of manufacturing. We're continuing to do longer shelf life studies on our products to determine the true shelf life of a product, but at least 2 years. I think the reality is in a freeze-dried format. 10 years. It's pretty, yeah, you know, conceivable.

So I've had clients who wanted to do DIY FMTs and they're like, okay, my nephews are really healthy. Or, and I then, but both nephews, we did a stool test and I'm like, yeah, no, he's got an overgrowth of H. pylori. And then the other one had some other pathogen in there. I'm like, this one's got C. diff in there. Like, I can't, I can't recommend that you put that into somebody's fragile health ecosystem. So I'm curious, like, are there, is a certain amount of C. diff okay? I'm not, C. diff, H. pylori okay? Like what, what is a something that we might normally consider pathogenic, but at a certain amount is okay in an FMT?

Well, this is interesting. I mean, in the context of H. pylori, we screen for it and like we had someone recently who on paper, perfect donor, the one thing that popped on them was H. pylori. And so we had to eliminate them from our donor pool.

So any H. pylori is a no-go for us.

Yeah. I, you might, but if you're using like Doctor's Data or GI-MAP or something, those aren't like gonna be that reliable when it comes to H. pylori. So I, I don't know.

Oh, you mean like an, a stool antigen test that's positive, not a, not a DNA, but not a metagenomic sequencing?

Yes. Yes. Yes. Right. But the reason I mentioned that is because actually in some research and I, and Denmark is an example where actually they don't exclude someone from being a donor if they have H. pylori but are asymptomatic because it's an indicator actually of overall a better microbiome, assuming they're asymptomatic. And so that's pretty interesting. I mean, you can Google this, right? Like look up the research. It's pretty fascinating.

Well, I mean, the entire book of Missing Microbes.

But we're regulated and that's one of the, that's one of the things that we can't have in our product. And so we don't allow that. But it's just an interesting fact and maybe eventually the regulations on that change. Probably they won't on that point because people broadly think of H. pylori as being like pathogenic and problematic. But when you look at the studies, it's actually showing they have broader microbial diversity. But yeah, to your point, I mean, I just broadly speaking, FMT is just so safe and so effective. I mean, that's like you look at all of the research and that's clear across the board. The issue that I've seen, you know, in all these years of interacting with patients is things has, has been in DIY FMT because this donor screening is not— that just like, they're not even able to access some of the labs that you might otherwise want access to do the testing. Like you just can't get the stool tests or you can't get access to the blood tests because they have to be infectious diseases and things that are only done at hospitals or something like that. And so I think you have to control for the risks and, you know, you don't want a product that's very successful but also has a potential for a lot of risk. And if someone is in compromised immune health or fragile in other ways, I just don't think the risk-benefit ratio is appropriate. But I also understand that people get so desperate that they're willing to just try anything. But where I have seen it go wrong is in DIY FMT. And there's this Netflix documentary, you might have seen it. I think it's called called Gut or something like that. And where she was using her boyfriend and some friend or something. And then she started getting some like anxiety, but like her boyfriend had anxiety and she's using her brother or something and he had acne and like, those things need to be controlled for. And if they're not being controlled for, there's a potential that those traits could be passed on. And so I think it's, it's a bit risky. I, as a fellow human and someone who sympathizes with these people who are really sick, I understand why you might resort to that desperate measure, but I, I do think it's, it's risky. And that's why FMT is now quite regulated is because of the potential risk.

Yeah. So what actual stool testing do you do on the donors?

Oh, it's exhaustive. I do not know off the top of my head, but it includes a whack of pathogens. Yeah.

Okay. So I mean, it's for the pathogens, but do you do something like a metagenomic sequencing or a, or a GI map?

Uh, we do, we've done that occasionally on donors, but it's all of the microbiome testing is hit and miss. Like, you know, you could send the same sample on the same day from the same patient, from the same stool, but just name it a different person's name and you're going to get a different result. I mean, I've done all this before, it's hit and miss. So we don't rely on that as like, this is a standard by which we're going to accept or eliminate donors. Out of interest sakes, I've spent like $700 on a microbiome test just out of curiosity, because I, you know, I enjoy they being learning about these different things, but we don't rely on them exclusively now.

Yeah, I've actually been thinking a lot about this, doing, doing exactly what you just said, taking one stool sample and sending it to 5 different labs and assuming that it, the ones that are the most similar are probably the correct ones. And if there's one that's like an outlier, that that's probably the incorrect one.

I mean, if I mix it up well, well, the, the better, the better way to gather the data is actually the same 1 sample, like 2 samples to the same lab from the same person, but just marked as a different person's name or a different day or something. You know, you got to be somewhat elusive. Although I don't even know if they track it. If it was the same person's name, they didn't run them through. But I've done it all before and this was some years ago, so it may have evolved or improved. But I know other clinics that are still doing this and still finding the same issues. I mean, that's broadly why you need to— that's not to throw shade at the stool testing companies. I think they're doing great work. I think, I think it just, you know, highlights the importance of interpreting them in the context of the patient's symptoms or what they're presenting with. So you can't just hold a, a result as like the be-all end-all. And I would have this discussion with patients. I'd say like, what's more important to you? Like having yellow going to green or you not having gas and bloating and fatigue? Like what's more important? And it always, it's like, well, I don't really care about the test. And so, okay, well then do Do you really wanna run it? Like you can, but if the test says you're worse, you feel better. Like what matters more? So I think it's just, it's all about, you know, you gotta educate the patient and in the context of full picture, it can be informative and direct them down a path where, but at the same time, some people won't make change unless they see it on a stool test or a urine test or a blood test or something.

Yeah.

And so I think it can be very useful and helpful, but it's still unfortunately quite limited in overall utility.

Yeah, I mean, I do. So I've, because of my job and as a podcaster and gut health coach, I've, I've gotten various free tests. I've paid for some, but you know, I've gotten a series of tests and I, and I've got post-infectious IBS. So for me it's just a game of whack-a-mole and it's like, okay, this test I've got a little bit of C. diff, the next test I've got a little bit of enterohemorrhagic E. coli, whatever it is. Cuz my, I'm, you know, people with this condition have I think are 3 times more susceptible to food poisoning. So it's just like whatever pathogen is passing through my body at that moment pops up on that test. And I guess in the same sense, we can often see those sort of things just come up in the, in patients, clients, et cetera, that they, you know, something was passing through their system at the time and, you know, maybe they were symptomatic, maybe they weren't depending on how much of other stuff is in their stool.

So it is right.

It is just a, a snapshot in time, even Taking into account the fact that the labs could be not fully accurate.

Yeah. I mean, I mean, that's the thing, right? Things are changing so quickly. Like if you shift your diet today, tomorrow your microbiome's shifting.

Oh yeah.

Like the changes are happening really quickly, which is also the good news here is that it doesn't take a lot. Little positive things cumulatively add up to make a significant overall difference and improve. So that is, you know, the good news here.

Yeah. Yeah. And I, um, I have noticed, you know, as I've started to add polyphenols and fibers and things like that, prebiotics, yeah, much more diverse microbiome, much nicer sort of overall picture, brought back things that had disappeared on certain stool tests. So it's, it is quite possible to, to make things change.

100%. Yeah.

Yeah.

And I mean, that's the like distinction between where someone's gonna potentially be a responder to FMT is, is if they've had a lot of antibiotics, they've totally wiped out strains by improving your diet or taking polyphenols and all these lovely things, they may never rebuild that again unless they're incorporating something like FMT. So there, you know, it varies, but, but yeah, that's, that's a great way to go. I mean, diet's always the foundation to improving anything.

So where can people find you and Novel Biome?

Sure. I mean, the most obvious is our website, www.novelbiome.com. You know, we got social media as is. I don't really personally have much of a personal brand, but, but you can find any one of our social medias, LinkedIn, YouTube, all that. We do a lot of it. We do put a lot of content out on YouTube and, you know, the podcasting platforms for Novel Biome where we talk all topics, FMT and gut microbiome and all the fun stuff. So definitely check those out, just searching Novel Biome. But otherwise, okay.

And if their doctor wanted to reach out about getting product, they would just go to your website and see where to do it Yeah. Okay. Yeah.

That's either reach out through our contact form or there's literally, they can register directly through our website and we review their account and set up a call and discuss their use case and how we can best support them with protocols and other educational tools and research.

Great. Well, thank you so much. This was interesting.

Thanks for having me. This was fun.

My pleasure. Well, that was an interesting conversation and He, he actually discussed with me after we got off the air a little bit more about the use of FMT in SIBO and even in post-infectious IBS. So that was a little bit of an intriguing nugget that makes me want to look further into that myself. You can support the podcast by buying supplements at a discount from my Fullscript dispensary, ordering tests at a discount from my Rupa Health Lab store, or using my affiliate links to iHerb, which is available worldwide, or Amazon. And just to note that you can use my Amazon link to buy anything. So as we approach the holiday season, I'd appreciate if you'd bookmark my link and use it not just for supplements, but for gifts and everyday items to support the podcast. One does not get rich as a health coach, so any affiliate income that I can bring in from Amazon and other affiliate programs really helps to support the podcast and the work I do with clients, which is very time consuming. So I'd love if you'd bookmark my link and use it for regular Amazon purchases. If you'd like to connect with me online, you can follow my High Desert Health Facebook page, join my Gut Healing Facebook group. Or join my newsletter list at HighDesertHealthCoaching.com, as well as follow me on X, Instagram, TikTok, and Pinterest. Links for those are in the show notes. Thanks for joining me today. Here's wishing you all the perfect stool.