The Food and Drug Administration (FDA) has granted Fast Track status to the microbiota transfer therapy (MTT), Full-Spectrum Microbiota (FSM), for the treatment of children with autism spectrum disorder (ASD).

As previous studies have suggested a link between the gut microbiome and autism-like behaviors, Finch Therapeutics, the developers of FSM therapy, conducted an open-label study in 18 children with ASD and chronic gastrointestinal (GI) problems to evaluate the effect of MTT on these patients.

Patients were administered 2 weeks of vancomycin treatment, followed by a bowel cleanse, and then high dose fecal microbiota transplant (FMT) for 1–2 days and daily lower doses for 7–8 weeks along with a stomach-acid suppressant. Results showed a 77% reduction in GI symptoms as well as a significant improvement in ASD symptoms (24% reduction in core symptoms), which persisted for at least 8 weeks post-treatment.

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To investigate the long-term safety and efficacy of FSM, the same patients were evaluated 2 years after completing treatment. Findings from this study showed that most improvements in GI symptoms were maintained and that ASD symptoms continued to improve.

“We are very encouraged by the preliminary clinical data in this field and look forward to conducting the randomized, controlled clinical trials necessary to fully assess the safety and efficacy of Full-Spectrum Microbiota therapy for the treatment of children with ASD.”

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