Tests fecal microbiota transplantation in children with autism and stomach symptoms
Tests gut bacteria transplant in children with autism and gastrointestinal symptoms.
Plain-language title generated from the registry record
Registry title: Open Label Phase IIa Trial Evaluating the Effect and Safety of Transplantation of Fecal Microbiota in Children With Autism Spectrum Disorders and Gastrointestinal Symptoms
Key facts
- Where
- Paris, FranceSee the site
- Phase
- Phase 2
Where in France
- Robert Debre hospitalParis, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT07105267EU 2025-520539-17-00
- Record updated
- 5 August 2025
- Original description
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.Read full original descriptionShow less
A Proof of Concept Study : 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.
Inclusion: ASD diagnosis based on DSM-5 criteria; Gastrointestinal symptoms: at least a score of 5 on 1 of the 5 GSRS domains (diarrhea, abdominal pain, constipation, indigestion, reflux) for over a period of 1 year or more; Age between 36 and 72 months; Consent from all legal guardians; Social insurance affiliation.
Exclusion: Recent change in ASD global care (cognitive behavioral therapy 6 weeks before inclusion); Actual or past psychotropic medication; Antibiotic or antifungal therapy 3 months before inclusion; Probiotics 2 months before inclusion or FMT 12 months before inclusion; Vancomycin or Picoprep® or Meopa (including excipients) known allergy or intolerance Experimental therapeutic trial participation 3 months before inclusion; Severe intellectual deficit (IQ<30) or another uncontrolled comorbidity (e.g. epilepsy); Inflammatory bowel disease; Undernutrition (age related BMI < 3rd percentile); Contraindications to colon preparation (Picoprep®) and/or to Meopa); Severe or uncontrolled gastrointestinal symptoms (e.g. urgent treatment needed); Exclusive diet (gluten- or sugar-free); Rectal enema contraindication.