Availability of MTT for the treatment of Autism in the US - March 2023
Fecal Microbiota Transplantation (FMT), also known as human probiotic infusion, bacteriotherapy, and fecal transplant, is a powerful infusion of healthy colon flora which has been used historically to treat patients with a variety of gut conditions, including clostridium difficile, aka C difficile infection, inflammatory bowel disease (crohn’s disease and ulcerative colitis), irritable bowel syndrome, autoimmune disease, dysbiotic gut flora and other lower GI conditions.
FMT treatments are currently only approved for use in the united states by the U.S. FDA for people with the aformentioned conditons and/or life-threatening severe diarrhea. The FDA does not allow FMT to be used for any other conditions in the united states until more research has been completed.
The Autism Research Team at ASU is currently doing research on a type of intensive FMT which they call Microbiota Transplant Therapy (MTT), in the hopes that it may eventually be approved by the U.S. FDA for use with those on the autistic spectrum.
MTT involves first using an antibiotic to kill pathogenic bacteria, then a bowel cleanse to remove remaining bacteria and the antibiotic, and then seven to eight weeks of full-spectrum microbiota, using gut bacteria from people who are neurotypical. The treatment involves 10 weeks of intense daily therapy.
The approach is based on pioneering research by Dr. Thomas Borody with the Centre for Digestive Diseases in Australia, who first used this method to successfully treat his patients with autism, and Professors Alex Khoruts and Michael Sadowsky at the University of Minnesota, who developed the methods for producing purified microbiota.
“[The FDA has] granted us fast-track status for the treatment,” explains Prof. Adams, “and we [have] moved on to Phase 2.”
This second phase began in 2017 and looks at 84 adults with autism. Originally a federally funded study, the pandemic intervened, delaying the research and slashing the funding.
By the end of treatment, there was an 80 percent reduction in symptoms of the gastrointestinal disorder and a 25 percent reduction in autism symptoms. The improvements remained when the researchers performed a follow-up exam eight weeks after treatment ended.
The U.S. FDA requires trials Phases 1, 2, and 3 prior to considering drugs for approval. The team hopes to start Phase 3, clinical trials with those on the spectrum, as soon as they have funding (see blue section, below). Once Phase 3 is completed, if the studies are successful, they will lead to FDA approval, and treatment availablility to the general U.S. population.
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