ASU’s Microbiota Transplant Therapy (MTT) reduced severe autism ratings from 83% to 17% over two years; Phase 3 trials now need funding for FDA approval.
Key Takeaways
Original 2017/2019 studies: n=18, no placebo; bowel cleanse followed by 7-8 weeks of fecal microbiota transplants boosted gut microbial diversity in autistic children.
Two-year follow-up showed autism symptoms down 45% from baseline; 44% of participants fell below the mild ASD threshold.
Phase 2 placebo-controlled adult trial showed statistically significant improvements in GI symptoms, receptive language, and overall autism symptom scores vs. placebo.
Gut-Brain Axis Therapeutics, spun out of ASU in 2022 via Skysong Innovations, holds the MTT patent and is raising for Phase 3.
Article is an updated 2019 piece, not a new publication; no new peer-reviewed paper is linked.
Hacker News Comment Review
Commenters flagged serious methodological concern: n=60 Phase 2 results are still pending quality review on ClinicalTrials.gov (NCT03408886), and history of small autism trials failing to replicate in larger studies warrants caution.
A recurring debate: autism is heterogeneous with strong genetic components, many children age out of severe diagnoses naturally, making symptom improvement hard to attribute to MTT alone without tight controls.
The university-to-spinout commercialization path drew scrutiny, though replies noted ASU likely retains patent ownership via Skysong Innovations and families of autistic children provided significant early funding.
Notable Comments
@Aurornis: Links ClinicalTrials.gov NCT03408886; results submitted but quality review incomplete – key caveat missing from the article.
@geremiiah: Raises natural maturation as alternative explanation for reclassification from severe to mild ASD over two years.
