Novel Biome's Treatment of Autism and Gut Issues through FMT
10 Jan 2023 · 42 min
In this episode of The Perfect Stool, host Lindsey Parsons interviews Dr. Shayna Kao, Director of Medical Communications and Affairs at Novel Biome, to discuss the company’s fecal microbiota transplantation (FMT) program focused on children with autism spectrum disorder (ASD) and related gastrointestinal (GI) issues. Dr. Kao explains Novel Biome’s origins, its four international treatment sites (Hungary, Panama, Mexico, Australia), and why the company concentrates on ASD – a population with a three‑fold higher prevalence of GI problems and a documented link between GI symptom severity and ASD‑related behaviors. The conversation covers donor selection (stringent screening, age limits, no antibiotics ever, vaginal birth, breastfeeding, diet, lifestyle, regular blood and stool testing, typically two donors per patient, and transparency with patients), stool processing (standardized, freeze‑drying, odorless, tasteless, capsule, powder, or enema formats), pretreatment protocols (individualized, often a short course of vancomycin or herbal antimicrobials, with a 2‑day high‑dose loading phase followed by 16 weeks of daily dosing), and delivery options (in‑clinic loading dose, at‑home capsules/powder, retention enema for children who cannot swallow). Dr. Kao shares observed outcomes: GI symptoms improve within 1–3 months; ASD‑related behaviors such as eye contact, speech, reduced stimming and aggression often improve after engraftment. Data collection includes stool microbiome sequencing, GI symptom scores, ASD behavioral scales (CARS and others), and quality‑of‑life measures; an internal observational study is tracking donor‑recipient matching. The interview also touches on regulatory challenges and past controversy surrounding Dr. Klopf’s use of FMT, the company’s response (enhanced manufacturing standards, Health Canada review, increased transparency, revised marketing), and the current status of Dr. Klopf’s credentials. Pricing is outlined ($14,300 USD for the standard 16‑week ASD protocol, with costs varying for other indications). Logistics include the ability to ship at‑home treatments for C. diff infection in the US, while other conditions may require clinic visits. Finally, Dr. Kao emphasizes individualized care, dietary and supplement guidance, and encourages listeners to book a free consult to assess fit.
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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. Shayna Kao, a neuroscientist with an interest in alternative medicines that utilize the body's innate systems with a passion for medical education and scientific communication. She received her doctoral degree in neuroscience from the University of British Columbia has been working in the field of medical affairs in non-traditional medicines for the last 3 years since leaving academia. She's currently the director of medical communications and affairs at Novel Biome, which provides high-quality, medically supervised fecal microbiota transplants, or FMT, for children with autism spectrum disorder, or ASD. Part of her role is to spread educational and scientific information about the microbiome and FMT that is accessible, accurate, and digestible. But before our conversation, if you haven't yet followed or subscribed to the show, be sure to do so. And if you want to get transcripts of the podcast, hop over to my website, HighDesertHealthCoaching.com, and sign up for my 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 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, Shayna.
Thanks for having me.
My pleasure. So why don't you start by telling us about Novel Biome and the work you're doing there with fecal microbiota transplants?
Yeah, so at Novel Biome, we focus on providing high-quality, medically supervised fecal microbiota transplantations, or FMT, and our focus is specifically on children or adults with autism spectrum disorder, though we do treat people outside of that, adults that have other conditions that can be helped with FMT. We have 4 treatment locations in Hungary, Panama, Mexico, and Australia. And we've expanded these to try to reduce the stress and burden it is to try to, to kind of access this level of treatment. And so we've been around since 2019 with a focus and being Novel Biome. And this came about, two studies were published in 2017 and 2019 by Dr. James Adams and his group out of Arizona State University.
Who we've had on the podcast twice.
Yeah. And so his work, I think. Really stimulated more interest in, in the possibilities of, of FMT with autism. And so parents started to reach out about maybe that FMT might be a good fit for their children. And that kind of has just expanded from there. And we've kind of focused in on ASD because we think that the research to date has been so valuable. But as well, children with autism spectrum disorder are 3 times more likely to have GI issues. These GI issues really impact quality of life and there seems to be some correlation between the severity of GI symptoms and the severity of ASD-related behaviors. And so there's a good groundwork of research that's been around for a long time tying gastrointestinal issues to children with autism. And so while this research in FMT is new, there's been an understanding that there is a GI component for not all children with autism, but a good proportion of children with autism. So that's what led us to do what we do. Yeah.
And so Dr. Klopp is from Canada originally.
Yes.
And, and so you're, where's your clinic there?
So we don't treat in Canada.
You don't?
In Canada, we're a biomanufacturing company for export. In working with Health Canada, Health Canada has, doesn't want FMT to be a treatment that's accessible right now to Canadians. So in working with them, we don't advertise, we don't treat Canadians, and our website's not even accessible in Canada. And we primarily just to work as a biomanufacturer, and that's in accordance and following all the rules with Health Canada. And, and they've evaluated and looked at everything and, and we're working towards getting a drug establishment license, which then further solidifies our export processes as a drug as well.
And then your clinic in, in Mexico, that's in Tijuana, right?
No, it's in Rosalía.
Is it, is it near California though?
It's like, yeah, so it's like driving distance. Not too far. Yeah.
Right.
From, from the US border. But it's— that's our closest, I guess, US site, and that one's been around for the longest. That was our first site, and then we've kind of expanded from there, working with clinics that have the capabilities and, and the understanding of FMT. We supply product and a protocol for them, and then they provide the treatment there.
And so why the focus on autism in particular? Does Dr. Klop have any particular relationship with that, or was more just because of the patients asking about it?
It's relationship with the patients asking, as well as that kind kind of being, having a good groundwork for why FMT would work. The research to date's been really good. And then that understanding of those GI symptoms, those are there. And so we know that there's a good groundwork of support for why this would work.
And what kind of GI issues do children with autism typically show?
Kind of runs the gamut. A lot of the major ones are a mixture of constipation and diarrhea, which oppose each other, but those tend to go to be the two. Bloating and abdominal pain seem to be the ones that we see the most in the literature. Those are the consistent ones that come up.
And these aren't just cases of SIBO that could be treated in a different way, or do you, do you deal with other potential treatments prior to going to FMT?
Yeah. So part of our protocol starts with a personalized pretreatment that's done by a physician's assistant. So they go through basically what's currently being treated, what tests have been done, what other tests should be done. What types of medication for before going into FMT? Sometimes we'll find out that there are larger mold issues and things like this, and then we'll hold off FMT, get all of those treatments done so that the gut is ready to take on FMT. So we do that. That's a case by case, and every case is different. So we make sure that we, we tackle any issues that could be solved before going into FMT. Okay.
And so what percentage of your practice would you say is children with autism versus other issues?
That's a good question. I would say probably 90% is, is autism. And most of those are gonna be children with autism. Not to say that children with autism are only coming for autism. So we also see some parents are, are really highlighting those gastrointestinal issues or IBS or IBD as well as seeing that their child also has autism. So it's not always just that parents come and they're like, we have an autistic child, we think FMT will help. It's often that, well, we have these like gastrointestinal issues that are causing a lot of issues, we'd like to tackle that. And if we see outcomes with autistic-related behaviors, that's also great. So that tries— that's what we try to instill, is that the first outcome is always going to be GI, but we see these secondary outcomes with autistic-related behaviors. So it's not that this is specifically a treatment for autism. It's, it's tackling one of the symptoms, which seems to be GI, which then leads to these secondary changes, which we don't understand at this point. The research is not there to understand why these changes are happening, but it is showing that there's a relationship between the two.
Okay, well, we can get more into the, the results in a minute, but first I wanted to ask about your donors. So who are your donors?
So we have really stringent donor screening characteristics that we look for. So there are published standards, there's about 9 of them that are out right now. And what we do is we look at what those initial screenings are, and then we have our own subset that we also look at on top of that. So we're looking for all of our donors not having taken antibiotics in their whole life, having been vaginally born and breastfed. And we know these things are the pillars of creating a stable gut microbiome from the beginning. And then of course we're looking for, looking at their diets as well as their exercise habits. And then we look at a wide variety of both in them and in their their family history of any disorders that we think could be or might soon be understood to be tied to the gut microbiome to try to reduce any transfer. So we screen our donors and that leaves us with very few donors that we can even use. And then outside of that, their blood and stool is tested and that's done regularly every 3 months to make sure that there's nothing there. And so like everywhere, we find donors that meet our requirements and then we use them as long as they're willing to donate.
And is there an upper limit for age with your donors?
Right now we don't have any donors over the age of 30. I mean, right now in the research they're saying there shouldn't be huge shifts in the gut microbiome until somewhere in the 60s, 70s range. But most of the published cutoffs are around 60, and we want to keep ours under that because we do know that there are changes, and not just changes in the gut microbiome, but changes in how people live as they get older, which then impact the gut microbiome. So we're trying to stay on the cusp of not having any of those issues. So right now we don't have anyone over the age of 30.
Is that, is that the exclusion age or is that just by chance?
By chance. Right now we don't— our exclusion age, I think in our written documents, I think is 40. So in that same range. But we just want to ensure because we know that age impacts it, we're still really understanding that. And when, when that shift happens. And there's a whole bunch of issues in the aging gut microbiome research that I could go on for days about. So I think we're just trying to stay on the cusp of like what we know for sure versus getting into ages where there might be impacts. And with, with FMT, the more you can control what is going on with your donors, the better, because we want to ensure what we're giving patients is consistent and safe. And so the more we can control what the donors is going to pass on, the better it is for the patients.
And do you allow your patients to see the donor screening questionnaire that you use with your donors?
Yeah. So any patient or anybody that wants to, to not kind of understand that, we can give that. And then anyone that goes through treatment can see the reports of the, the blood and stool screening and stuff like that from the donors. But that stuff we have to be somewhat mindful of because it's their health records. So we can give a general understanding of what the donors have that they've passed. All of these screenings, but we can't give everybody like, here, who are these people? This is where they live. This is everything they do, right? Because that's— we also have to protect the donors themselves. So there is some information we can provide and there's some information we just can't provide. But we try to be as transparent as possible where privacy allows us.
Sure.
But yeah, our donor screening and all that stuff is, is something that is readily available for anyone that asks. It's not on our website because it's a very long—
would it be something that we could share? I could share with my audience. Would you be willing to?
Yeah, I can send the, the, the questionnaire to you. It's a couple pages long, but awesome. Yeah, that's easy enough.
I can post that in my show notes.
Yeah. Cool.
And what about, can your patients see the pictures of the stool prior to processing?
I can't guarantee you that anyone's ever asked. We do. So we use the Bristol stool chart. And so there's a cutoff where like, if stool don't fall in these two categories, we don't use it.
3 and 4.
Yeah. But outside of that, that's, that's all there is. I don't know if we take pictures of it. We have a lab manager who does all of those things, but I highly doubt.
But if someone asked, they might be able to.
Yeah, I think if someone really needed to. But I think what it is, is like, this is the categories they fall into and, and anything that falls out of that is always documented. And of course, that donor is not used. And then we categorize that donor until they're back into that time period and figure out what could have happened as well. So that's we wanna make sure we're only using the best. And so that's not part of my job, but part of hers.
Okay. And do patients get stool pretty much from one donor or is it mixed together with multiple donors?
We use donors, we usually use at least 2 donors for patients. And we just wanna make sure that the goal here is that like it's diversity, ensuring that you get everything you can. And so by using 2 donors, we actually suggest people rotate back and forth between what donor they're taking, so that we can get the best benefits. There's some disagreement and, and some agreement about using multiple donors versus one, but most of what we've read in the literature seems to support the uses. There's a benefit to having multiple donors versus just a single donor. So we're hedging our bets with that. Mm-hmm.
And how do you process your stool for transplant?
That would be a good question for our lab manager. I've, toward our lab, I have not watched her process anything because she's very picky about cleanliness and who's around when she's doing stuff, which I appreciate wholeheartedly. But that would be something that she would know more about than I do.
Well, maybe you could get, ask her, and then I could just put a little paragraph in the show notes afterwards about what the process is.
Yeah, we have like standardized procedures, so I didn't think it'd be hard for her to pull, but that's not something I know anything about off the top of my head.
And so what is your protocol for preparing the recipient for the transplant? Do they take antibiotics? What's—
Yeah, so most of the time everyone is going to take an antibiotic, but it's, it's individualized. So that's part of our process is that we work with parents and their children to see what is necessary for them to be prepared. I think we're as a, as a field are starting to really understand the importance of pretreatment. There's been some new studies that have come out and said that like In cases where antibiotics were done before FMT, there's more success there. So that is one of our standards, but it's not consistent and not everybody takes antibiotics. That's also dependent on the comfort levels and where we think. Some parents don't feel comfortable and we use alternatives to antibiotics, but it's, it really is, it's completely individualized for the person. So there's no like, here are the 3 steps we use for everybody, cuz those, no person fits perfectly into a puzzle every time, so we alter it depending on, on them.
Okay. So if you didn't use antibiotics, would you use herbal antimicrobials?
From my understanding, that has been done. I mean, consistently it is almost always antibiotics, but for people who don't feel comfortable, we use a natural alternative to an antibiotic.
And is there a particular antibiotic that you prefer?
I think it's normally vancomycin, but I can't be 100% sure because that—
That's what I've heard from, I think, Dr. Adams.
Yeah.
Okay. And then how long is the course of treatment?
Our protocol, we do a 2-day high dose and that's gonna be at one of our treatment centers. And then we, the total protocol is 16 weeks of FMT treatment. So after those 2 loading doses, yeah, a daily, daily for 16 weeks. And so we do that because there seems to be a huge impact on the amount of time that treatment is done. Studies that have done 4 weeks versus something like Dr. Adams study, which did 8, you see significant improvements. We've extended that. Extended ours and we see more consistent outcomes. And we think part of that is because of that kind of extended treatment period.
And are these all being done by like retention enema or is this, is this, are you doing capsules or?
Yeah, so we have at our treatment centers, you can do either an enema or loading oral dose and that depends on, on the child or, or the person getting treatment. Some children can't take capsules, so they will take a retention enema and then when they go home For kids that can take capsules, they'll continuously take the capsules. Anyone that can't swallow capsules, we have an oral powder which can be mixed with water, juice, milk, and so then they can take it that way versus having to take a capsule.
Okay. So it's highly purified the way that Dr. Adams' stool is to the point where it's not, it doesn't, doesn't resemble fecal matter anymore, I assume.
Yeah. So it's odorless, tasteless, colorless.
Just the bacteria.
Yeah. And so that allows us to, to provide an at-home version of the treatment for kids that can't take capsules. And that's really common in smaller kids. And so that allows a comfort for that. And then it's easy to kind of mix it into something they would normally drink anyways.
So it's really just a, a fancy probiotic pulled from someone's stool when push comes to shove. Excuse this brief interruption, but I wanted to remind you that if you've been struggling with IBS, IBD, reflux, gastritis, SIBO, dysbiosis, candida, diarrhea, constipation, and all that gut health stuff. That's my specialty. So I work with clients not just here in Tucson, Arizona, where I live, but also virtually on video chat. And I offer single appointments as well as a 5-session gut health program for people with tougher gut health issues or mental health or autoimmune challenges that go along with that, who likely require testing and longer-term follow-up as well as 12-week programs for weight loss. If you think that a 5-session or longer course of health coaching might help you meet your health goals, you can set up a free 30-minute breakthrough session with me to talk about what you've been going through, and I'll listen and hear if it sounds like I have something in my toolkit that you haven't already tried and let you know if I think that health coaching would be appropriate for you. You can find a link for that in the show notes, and I hope to hear from you.
It's, it's an engraftable, I guess, probiotic. It's so, it's because it's, it's a higher diversity and it's, you're getting everything. It's not—
and including the anaerobic strains and— yeah.
And it's, and it's not all— everything that's in your gut microbiota aren't bacteria. There's a whole host of things, right? So you're getting all of that. And with a probiotic, it's, it tends to be concentrated on a couple of strains.
Right.
And we know that probiotics don't engraft. So they're good while you're taking them, not good long-term. So there is a difference, but I think because it's purified, and it's partially freeze-dried, you're looking at a more stable and something that can be used for a longer period of time. So there are some, there are differences, and as FMT is coming along, we're seeing these improvements. Oral capsules weren't a thing a couple of years ago. That's really kind of changing what FMT looks like and its accessibility, but as well now being able to partially or fully freeze-dry it. Now it's becoming more, call it shelf stable, but it, it's the life, the long hood, the long, long, the longness of it, how you can store it and how it's able to be stored and then shipped and and then stored in someone's house for longer periods of time makes it an easier product to have.
Does it have to be refrigerated?
For extended periods, so we suggest 4 degrees storage because what we've seen in so far that's been done, and we're doing our own stability studies to get a better understanding 'cause there hasn't been a ton done, but when it's at 4 degrees, when it's been partially freeze-dried, we know that it's good for up to about a year. So we suggest keeping it in the fridge and then keeping it at a consistent temperature because those temperature variations can cause some, some issues as well.
So is that 4 degrees a typical— this is Celsius, right?
Celsius. Yes. I don't speak Fahrenheit. I apologize.
Standard fridge temperature, which is the, which is, I think somewhere around like 40 degrees Fahrenheit or something like that.
Yeah.
Okay. And what gut health conditions does the research say are most positively impacted by FMT?
It's a wide variety and we're still learning. I think the biggest thing to say is currently it's only approved for treating recurrent C. diff in the US, and the outcomes of that are magical. And because that it's been so safe and consistent, research is growing in other areas across the board. We need more randomized clinical trials, we need larger clinical trials, and we need more patients to see consistency. So I think that's like the first statement to make across the board. For irritable bowel disease, there have been a number of positive studies. While the results aren't what we're seeing in, in C. diff, which is like 90%, it can— it seems to be consistently around somewhere between 30% improvements. But irritable bowel syndrome, inflammatory bowel disease, irritable bowel disease, and there's no consistency in like the— like there's been 10 studies done in Crohn's and that's—
we're talking about Crohn's and colitis, inflammatory bowel disease.
Yes. And so that's around— they're showing about around 30%. But because diseases that fall under IBD are inflammatory in nature and they're cyclical, I think that's what we're seeing in the research is that when people aren't in an inflammatory state, their response is different than when they are. So that's complicating, I think, the research a little bit is that this— there are certain disorders when you treat will also matter. There's some really great new clinical trials coming out for Parkinson's disease. The stuff that's been done to date has kind of been case studies and preclinical. Which are promising. And there's a number, I think there's 4 clinical trials coming that are currently undergoing for Parkinson's disease. There's a couple for MS, multiple sclerosis, autism spectrum disorder. Of course, we're seeing clinical trials and growth in research there. There's been some research looking at in cancers, not spec— there is some stuff specifically for cancer, but a lot of the research right now is looking at treating side effects of cancer treatment. Treatments. So the biggest beacon we're seeing is that people who are getting stem cell treatments or bone marrow treatments, because of what has to be done to prep the body to get those treatments, they're actually finding using either FMT or autologous fecal microbiota transplantation, which is using someone's own stool. They take the stool before they get any of the prep done for the, for the stem cell treatment, and then do the, their AFMT. And they actually see that that improves both uptake and any issues with graft versus host, but as it's just, it makes the process more enjoyable or easier, reduces side effects. Where else is it? IBS is another one that they're showing studies in, which shows it seems to be a little bit more consistent than IBD, which I think is like 40 to 50% improvement. But that's not, there's not a ton of studies. And again, there's more coming. There's the clinical trials are growing in this area, but those are kind of the main areas we're seeing a lot of growth in research.
Okay, cool. That was a good summary. And so I know that there was some controversy surrounding Dr. Klop and his use of FMT. So can, can you explain a little bit about what's going on with that?
Yeah, so we're still in the midst of it. It's been going on for too long. It started in 2020, where the main issues that came out, and a lot of it was around manufacturing standards, the use of FMT in children with autism spectrum disorder and advertising. So we've completely revamped how we advertise, and that's something that network consistently and changing as we enter new, new countries. We're working with external help with that because none of us are marketing people. So we're learning about that as well. And then as well as in, in Canada, I've worked with Health Canada to decide to not advertise and we, we don't treat Canadians. So that's been part of the change as well for our manufacturing standards. We've had Health Canada in, they've looked at our procedures, they've looked at our laboratory. And for us, Health Canada is the governing body, um, health body here, similar to the FDA in the States. And so we've been investigated, cleared of any deviations from acceptable procedures. We have a beautiful and wonderful lab. I am jealous of it. I, I worked for a very long time in labs and it is, it is very pretty and clean and nice. I wish that's where I worked previously, but I think that's, we're working with governing health bodies, making sure we're meeting all their requirements., and that's all we can do. Unfortunately, none of those things have been picked up by the media, but everything else seems to continue to live there. And then we've reevaluated how much information we put out into the public. We didn't put a lot out there, so we like completely revamped our website. We're more transparent about our donor screening and our screening that we do to blood and stool. We also have really put our, put our time into providing education. What is FMT and why is it important? These are things that there's not a lot out there.. And some of the research that out, out is out there is really hard to kind of digest. So we've taken it upon ourselves to try to provide easily accessible education so people can understand what FMT is and what we know about it right now. And those are like how we've decided to tackle the negative attention we've gotten is by evaluating what we were doing and why this could have happened. And so our first thought was, well, we weren't, while we've always been science driven, we weren't being parent enough about that. And then when it comes to manufacturing, we're on the up and up. We've been evaluated by everyone that matters for that, and that's all we can do. But hopefully—
and I know Dr. Klopf's credentials were threatened. Does— has that been resolved?
We're waiting for, for the decisions on that. And—
but he currently still has them?
Yeah, so he's still a naturopathic doctor. Yeah, it's just—
okay. Yeah. Just wanted to make sure. Okay. And so I know you were tracking your results internally.
Yep.
Are you tracking them with regard to certain, the particular donors or just in general?
Yeah. So we, right now we internally, we collect a number of measures from our patients. So before, during, and after FMT to monitor changes, what we're looking at across, we look at stool, we also look at GI symptoms, and then we look at a number of measures specifically associated associated with ASD. And we also have a new observational study with Biome that we're looking at. It's— the first thing is looking at the gut microbiome of children with autism to get a better understanding of what are the markers, what's different about their gut microbiome. And then the second part is we understand that there is an importance to donor and recipient matching. I think as the field grows, we're seeing that more and more. So in this study, what we're doing is we're measuring our donors as well as measuring our patients. But then measuring how, what the interactions and what the changes are based on how similar or different those gut microbiomes are and what the outcomes look like. So we're, we're in the process of collecting data to understand the, the donor recipient relationship as part of our, our efforts to increase the research and data that exists.
Have you had positive results or negative results with certain donors that have led you to no longer retain them or—
No, we haven't had any donors that we've, we've not used. I think because the— to become a donor is, is so stringent. I think standard, like based on what's been published, it's about 50 to 80% of people don't pass the initial screening. Our screening's even in even a higher level than that because in a lot of cases it's like you haven't had antibiotics in 3 to 6 months. We've just— you've never had them. And we tend to kind of go to the extremes for a lot of things to ensure that we're not missing anything. So the number of donors you even get just past that initial screening is so few. And then on top of that, their blood and stool is screened and then regularly screened, that the likelihood that a donor has something that's specifically not good is, is very low. And then we retain our donors as long as possible because they're really hard to replace.
Right. Are they coming in every day, basically?
Yeah.
Dropping off their samples. Yeah. And And these are all in Canada, right? Yes.
So every— you have to be close to our site. So we're in Chilliwack, BC, so they would all be within an easy driving distance. Okay.
So let's get to the kinds of success you've seen with FMT and ASD and other conditions.
Yeah. So I'll focus just on ASD because that's where we have the most. I don't like to make conclusions about small things, but— Okay. We do. We know that the process is like— we know that when children take antibiotics, we do see changes in their behaviors. And, and then when you start FMT, there's always a period of time where you see changes that increases in hyperactivity, increases in some, some behaviors. And we see that basically once we think that the gut microbiome has started to kind of engraft and become part of the system, you start to see improvements. Consistent.
And how long does that take?
Varies, but most of our patients say between, between the first and the third month, they start to see consistent improvements. In the first couple of weeks, they seem to, it's just the change. I think a mixture of wiping out the first gut microbiome and engrafting the next one, you see a lot of changes before you see consistent improvements. We see those going into that 1 to 3 month mark. We see improvements, uh, GI symptoms seem to be consistently improved, and that's supported in the research. And then The ASD-related improvements do vary, but a lot of them are the improvements in eye contact, improvements in speech seem to be something we see consistently, and then consistencies in behaviors. So a reduction in stimming behavior and a reduction in aggressive behavior seem to be ones that we see more consistently. But we're in the process of kind of providing— we're in the process of collecting more consistent data over longer periods of time so that we can start Our goal is to publish it so that it's readily available for people to see so that we have consistent data points that are done regularly and done by validated measures. So we were only originally using one validated measure. We're now using three, and we're also looking at quality of life changes, which is something we want to have a consistent measure on. But these are all things that we've added in the last 6 months. So we're still collecting data because our process takes so long. We have a 16-week treatment period. We're just now starting to get people through their second— they're like end of FMT and then their follow-up. We're just now getting those data. So we're a little bit further away from having conclusive, I think, statements. But from what we've seen previously and what's been reported from parents, the results— those results are consistent and people do see changes and improvements in their quality of life. But we want to have objective measures, of course, you know, across the board because everybody's perception of these things is different. So we want to make sure that it validated way of saying anything.
And are you also recommending diet changes or supplements in addition?
Yeah. So we do consultations with our physician's assistant at the beginning, in the middle of FMT, and at the end of FMT. And so that's used to monitor what changes are happening, answer any questions, but as well as put in place any supplements or, or anything that should be added to help help stabilize that gut microbiome and feed it. And then we also work with parents by trying to provide them with information around what diets, what things in the diet are important, and to make sure that they understand what you eat, what you eat feeds that gut microbiome. And so you have to diversify the gut by diversifying the diet, ensure that you're feeding every aspect of this new bacterial body that's there. And so we try to provide them with information and we're consistently researching what is the most important things in the diet that are best for the gut microbiome so that we can provide that. We always suggest like you should eat 50 different foods every week. And so we try to help parents get to that point. Kids with ASD often have a lot of issues with certain specific foods. So it's what creative ways are there to, to increase what they're eating and then what foods to focus on first. So that's all stuff that we provide as the process goes along and try our best to answer their questions about, and it ranges from like, or is this Is this pack of lettuce better than this because it has more things? To also like what types of, what types of smoothies are better to ensure that they have the most support we can give them because it is a huge shift. But the more you can do that, the better the gut microbiome will be. And that's the goal is to make a stable, healthy gut microbiome for once it's been transferred.
And what supplements do you typically recommend?
I could not tell you off the top of my head, mostly because it's individualized, like, and I've said that before, but it really is like each person depending on what they were taking before they started. Some people come to us with a very short list. Some people have a very long list of stuff that their children are already taking, and some of those are like, we have to take some of these off, some of them that we add on for other people. So it really depends on each child and where their starting point is and where they end up as they go through the process.
And is there any case study that you could highlight, any individual child that you could talk about just to, just to get an idea of what's going on?
We have done interviews and stuff with parents, like what improvements they've seen, but it really is dependent on where the children started. We treat children that start as having, being categorized as mild, as well as being categorized as severe. And those journeys look completely different because of what's going to change and what the driving force was. But a lot of parents consistently say that they're able to go about each day easier. And some of those things we talk to parents at the beginning of their journey, and it's the first things that start for them, is being able to get their child to have their coat on and into the car has now been less of a battle. And that's for some people, that's where it starts and it continues to go forward, being able to have a conversation for them to feel like their child understands them, to be able to integrate more easily. For a lot of parents too, is that everyone can eat the same food at dinner. And so these are changes that that happen throughout the process that make huge impacts for quality of life for both the child and the family. And those continue to go. And so it's not always specifically about different changes in their diet or in specific ASD-related behaviors that, like stimming or eye contact or aggression. It's also about, like, those changes all coming together to make life easier. And I think that's what we hear parents talk about about the most is just like the changes in their day-to-day lifestyle and how things have become easier. So I think outside of what you expect to see in changes in, in ASD-related behaviors and GI symptoms, it's that changes in quality of life as well as what a lot of parents talk about.
And so if somebody's coming to you for something else like, like IBD or IBS, is it a, is it a much shorter protocol?
From what I understand it is, it's average, it's between 2 to 3, 2 to 4 months depending on the person and, and what their journey looks like and where they're starting. But it's, again, our process starts always with a call and you talk to someone on our team and we get a better understanding of why you think FMT would be a good fit, what your current situation looks like. And then that starts the process of like, okay, is this a good fit for you or not? And then you meet with a physician's assistant to talk about what issues you're having, what kind of reports you have from your doctors to see, okay, so like what, where are we right now and where do we want to be? And then that determines the length of treatment and how we approach your pretreatment and your post-treatment as well.
And roughly how much does this cost for ASD or for shorter conditions?
So for our ASD protocol, which includes meeting with a physician's assistant, meeting with a behavioral, a behavioral or clinician who does assessments, we use the CARS assessment as well as the treatment and treatment at our, our sites. It's $14,300 US. And then that's kind of our standard. But if you're coming to us with something else, that would be dependent on the length of treatment and if it would all be at home or if you would be coming to one of the sites as well.
So Oh, so it is possible to, to just do it at home?
Depending on who you're referred by. So we have, we have patients that come to us for C. diff, and so their gastroenterologist or their, their doctor will send us a request form and then we can send out just an at-home treatment for them to do.
So, okay. Can you send out at-home treatments for people in the US?
Yeah. So for, for C. diff, we have done that.
But not for like IBS or IBD?
That would, that would be something that you would talk to the team about because it would depend, like for some people that having those loading doses would be a requirement. So it would depend on where they are and what works. And if it at home is the best thing, then we work with them and their doctors to ensure that we can get it to them at home.
Okay. But they have to come in via one of your clinics in those various countries.
Or they can have their doctor submit a request form for, for treatment, and then we can send it directly to them. Gives us some flexibility, but it would have to come as a request from a physician. And that's the way that we can do it.
Okay. Because I know that obviously in the US right now, it's only FDA approved for recurrent C. diff. So I'm curious how that works, just because if a physician requests it, does it somehow get around that rule?
I don't know. So that's Yes. So like our, all of our stuff has been done for C. diff. I think for all of our secondary patients, it would depend on, on their case and that stuff I don't know about because I don't work directly with patients. Okay. Because I have a PhD and not an MD, so they keep me away from all the people. But we know we do have cases where like we work with them to try to make sure that the process is something that can be handled, but I'm, I'm not sure how it works and it may be country specific cuz for each country, the rules around FMT are different and we treat globally. So that's why we always say, talk to the team, we'll figure out where you are and what the rules are where you are, and then how to kind of—
okay, like you might be able to refer them to a doctor in their area.
Yeah. And if they're in a different country where FMT is regulated differently than it is in the US, then the procedure would be different because it always depends on what the health authority there is requesting and what the procedures are. So like, you know, we treat in the US, but we don't treat at all in Canada. But we have patients in Europe and South America, everywhere. So it's dependent on where they're located. So I think the procedure depends. And that's why I always say, like, the best thing to do is, is book a call and talk with us, and we can work through all of that, because there is a lot of legality and, and rules around where you're located and how treatment can be done. So it's hard to make a singular statement, I Yes. Um, yeah.
Is there anything else you would like to share before we finish up?
I think just that if you have questions about FMT or if you think FMT might be a good fit for you, we have— the way that we approach it is, is book a call and ask questions and see where it is because it is something that's growing and we're understanding more and more about it. But I think for every person it's gonna be different and our goal is to ensure that you're informed and that that you have an understanding of what the possibilities are. And so I think that's always the best, is to just do your own research, look at our website. We have a YouTube channel where we make educational videos if you want to get a better understanding of what FMT actually is or what the gut microbiome is. But then book a call and talk with someone on our team to get an understanding if it is a good fit for you.
And do you— is there a cost for that initial call? No.
So It's, it's, there's no cost and there's no, there's no, you're not tied into anything. We're just as likely to say it's not a good fit for you because we want to, we want to make sure that anyone that's coming to treatment with us is getting treatment that we think will work or will be a good fit. And it may be that maybe it's not a good fit for you now, or maybe we don't think that it will be, be helpful for the, the symptoms that you have. Just as much as we want to answer your questions for you to say, be informed about making that decision. So we have that as an open-ended so you can you don't feel locked in, you don't feel tied up with anything, and then you can get an understanding of how it fits for you.
Okay, awesome. Well, thank you so much for sharing about all this. I'm sure that there's a lot of people who are curious about it and considering it. So, perfect.
Thank you.
Appreciate, uh, you coming on.
Thank you so much.
Well, it's nice now that there's another option that's close to the US for FMT and not just for ASD, but for other conditions. Lindsey Parsons. So if you're a longtime listener or you're getting a lot of useful information from the podcast, please consider becoming a regular supporter on Patreon. And 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. And I'm also on Twitter, Instagram, and Pinterest. Links for those are in the show notes. Thanks for joining me today, and here's wishing you all the perfect stool.
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