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

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-04-01

Summary

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.

• Phase: PHASE2

Details

• Lead Sponsor: Assistance Publique - Hpitaux de Paris
• Collaborators: Biocodex microbiota fondation; Fondation Erie; Fondation initiative autisme
• Treatments: FMT protocol