Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT07105267
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* Severe intellectual deficit (IQ\<30) or another uncontrolled comorbidity (e.g. epilepsy)
* 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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
36 Months
Maximum Age:
72 Months
Study:
NCT07105267
Study Brief:
Protocol Section:
NCT07105267