Fecal transplants for autism deliver success in clinical trials (2019)

Study results and claims

• The pediatric open-label study reported large changes in autism ratings two years post-treatment (most moving from “severe” to mild or below diagnostic cutoff).
• Later adult, placebo-controlled data (trial NCT03408886) reportedly show modest additional improvement in autism symptoms vs placebo and larger gains for GI symptoms, but detailed, peer‑reviewed results are not yet public.
• Some readers see the magnitude of reported pediatric improvement as potentially transformative if real, especially for families dealing with severe GI comorbidities.

Skepticism about efficacy and methodology

• Many highlight the lack of control group in the early pediatric study and the small sample size (n≈18), making maturation, therapy, and other changes plausible explanations.
• Concerns about p‑hacking and the common pattern in autism research: dramatic small open-label results that fail or shrink in larger randomized trials.
• Questions raised about trial design for some competing products (e.g., long periods of invasive procedures only in the active arm), which could themselves change behavior independent of microbiome effects.

Gut microbiome, GI symptoms, and diet

• Strong interest in the gut–brain axis: chronic GI pain, constipation, and dysbiosis may worsen behaviors scored as “autism symptoms.”
• Many autistic people have extremely restrictive diets, which can cause serious deficiencies and distorted microbiota; repairing GI health might reduce distress and thereby improve functioning.
• Others warn of a “microbiome hype train”: some studies find only weak or no association between ASD and gut flora once confounders are controlled.

Delivery methods and practical issues

• Discussion of routes: nasogastric tube to upper intestine, colonoscopic/enema delivery, and “poop pills.”
• Volume is a challenge for capsules; pills typically imply lower doses or repeated courses.
• Some argue that long‑term benefit likely also requires ongoing dietary change, not just a one‑time transplant.

Commercialization and PR

• The bacterial formulation is patented and spun out into a company; this is described as common university practice but ethically contentious, given public funding.
• Skepticism that recent “updated” coverage is driven more by corporate PR and fundraising than by fully published phase 2 data.

Autism, diagnosis, and masking

• Clarification that studies measure changes in diagnosed ASD severity, not a literal removal of autism as a neurotype.
• Several commenters argue that relieving GI distress may simply make it easier to cope and “mask,” lowering symptom scores without changing underlying autism.