Open Label Phase IIa Trial Evaluating the Effect and Safety of Transplantation of Fecal Microbiota in Children With Autism Spectrum Disorders and Gastrointestinal Symptoms

Autism Spectrum Disorders (ASD), affect approximately 1% of the general population and are characterized by impairments in social communication associated with repetitive/stereotyped behaviors. Approximately one-third of these patients display gastrointestinal (GI) symptoms, and a growing number of studies suggest abnormalities of gut microbiota in ASD. Gut microbiota and the brain interact through complex pathways. Preliminary evidence in adults with ASD suggests that modulation of the gut microbiota by probiotics and/or prebiotics and more recently by fecal microbiota transplantation could improve GI symptoms but also socio-communication deficit, with persistent improvement at year 2.

NCT Number	NCT07105267
Lead Sponsor	Assistance Publique - Hôpitaux de Paris Collaborators: Fondation initiative autisme, Fondation Erie, Biocodex microbiota fondation
Conditions	Autism Spectrum Disorder, Fecal Microbiota Transplantation (FMT)
Enrollment	5 participants
Start Date	2025-09-01
Primary Completion	2027-04-01 (estimated)
Study Completion	2027-04-01 (estimated)
Updated on ClinicalTrials.gov	2025-08-05