Evaluating Fecal Microbiota Transplantation for Improving Gastrointestinal and Behavioral Symptoms in Children and Young Adults With Autism Spectrum Disorder

What this Trial Is About

Researchers are studying the effects of fecal microbiota transplantation FMT on children and adults aged 7 to 30 with autism spectrum disorder ASD who also have gastrointestinal problems. The study aims to see if FMT can improve gastrointestinal symptoms, autistic behaviors, emotional and behavioral symptoms, and sleep. It also explores the relationship between the brain-gut axis, immune system markers, and ASD. Early treatment during school age may improve development, cognition, and long-term outcomes for children with ASD. Participants will receive FMT by transplanting fecal microbiota from healthy donors into their intestines via colonoscopy. Donors are thoroughly screened to ensure safety, and patients undergo colon preparation before transplantation. After the first treatment, a second transplantation will be arranged six months later. Patients will be monitored closely for 24 hours after each procedure to ensure safety. Throughout the one-year study, participants will provide blood and stool samples before and after treatment to analyze changes in gut bacteria and immune markers. Researchers will assess gastrointestinal, autistic, emotional, and behavioral symptoms using questionnaires, along with sleep patterns and cognitive functions through actigraphy and attention tests. The study will compare results before and after FMT and with a waiting list group to evaluate the treatments effects over time.

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.