NCT07105267Not yet recruitingPhase 2
Open Label Phase IIa Trial Evaluating the Effect and Safety of Transplantation of Fecal Microbiota in Children With Autism Spectrum Disorders and Gastrointestinal Symptoms
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Autism
- NCT number
- NCT07105267
- EU CT number
- 2025-520539-17-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 5
- From 1 Sept 2025 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Severe intellectual deficit (IQ\<30) or another uncontrolled comorbidity (e.g. epilepsy)
- Inflammatory bowel disease
Age
- Undernutrition (age related BMI \< 3rd percentile)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 36 months to 72 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Robert Debre hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.