Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study.
Level 4 - case-series / case-control
Uncontrolled open-label interventional study (case series)
PubMed 28122648 · doi:10.1186/s40168-016-0225-7
What was done
An open-label trial evaluated Microbiota Transfer Therapy (MTT) in 18 children diagnosed with autism spectrum disorder (ASD) and gastrointestinal (GI) symptoms. The protocol comprised a 2-week course of oral antibiotics, a bowel cleanse, and an extended fecal microbiota transplant protocol featuring a high initial dose followed by daily lower maintenance doses for 7–8 weeks. Outcomes evaluated included changes on the Gastrointestinal Symptom Rating Scale (GSRS), standardized clinical behavioral assessments, and deep sequencing analysis of bacterial and phage gut communities at the end of treatment and 8 weeks post-treatment.
What was found
The Gastrointestinal Symptom Rating Scale showed an approximately 80% reduction in GI symptoms at the end of treatment, with significant improvements across constipation, diarrhea, indigestion, and abdominal pain that persisted 8 weeks post-treatment. Behavioral ASD symptoms also improved significantly and remained improved at the 8-week follow-up. Sequencing demonstrated partial donor microbiota engraftment, increased overall bacterial diversity, and persistent increases in specific taxa, including Bifidobacterium, Prevotella, and Desulfovibrio.
Why it matters
The study provides proof-of-concept human data suggesting that extended microbiota transfer can modify gut microbial composition and is correlated with improvements in both gut and behavioral symptoms in ASD.
Limits
The study was small (n = 18), open-label, and lacked a control or placebo group, introducing substantial risk of placebo effect, observer bias, and regression to the mean. The combination protocol (antibiotics, bowel cleanse, and extended FMT) makes it impossible to isolate the specific contribution of the transplant itself. Follow-up was limited to 8 weeks after treatment cessation.
Cited by
- supports A collaborative study involving the University of Arizona and Dr. Alessio Fasano found significant improvement in gastrointestinal symptoms in children with autism spectrum disorder following fecal microbiota transplantation.