Novel Biome's Treatment of Autism and Gut Issues through FMT

10 Jan 2023 · 42 min
The Perfect Stool Understanding and Healing the Gut Microbiome

10 Jan 2023 · 42 min

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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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