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FELICITA - 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
EU CTIS ID: 2025-520539-17-00
What this study is testing
Assess initial efficacy on gastrointestinal symptoms of fecal microbiota transplantation in children (36 to 72 months) with autism spectrum disorders at week 18
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ASD diagnosis based on DSM-5 criteria
- Gastrointestinal symptoms: at least 1 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
You likely can't join if
- Severe intellectual deficit (IQ<30) or another uncontrolled comorbidity (e.g. epilepsy)
- 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
- Recent change in ASD global care (cognitive behavioral therapy 6 weeks before inclusion)
See the full eligibility criteria
- ASD diagnosis based on DSM-5 criteria
- Gastrointestinal symptoms: at least 1 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
- Severe intellectual deficit (IQ<30) or another uncontrolled comorbidity (e.g. epilepsy)
- 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
- Recent change in ASD global care (cognitive behavioral therapy 6 weeks before inclusion)
- Actual or past psychotropic medication
- Contraindications to colon preparation (Picoprep®) and/or to Meopa®)
- Severe or uncontrolled gastrointestinal symptoms (e.g. urgent treatment needed)
- Undernutrition (age related BMI < 3rd percentile)
- Inflammatory bowel disease
- Exclusive diet (gluten- or sugar-free)
- Rectal enema contraindication
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.