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

Assistance Publique - Hôpitaux de Paris

Status and phase

Not yet enrolling

Phase 2

Conditions

Autism Spectrum Disorder

Fecal Microbiota Transplantation (FMT)

Treatments

Drug: FMT Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT07105267

APHP241418

2025-520539-17-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full description

Screening :

Screening will be done in ASD units of child psychiatry departments of Robert Debré
Information of patients and their families Information will be delivered in the child psychiatry department of Robert Debré hospital.
Inclusion Consent will be collected in CIC of Robert Debré hospital during the initial visit by child psychiatrist 7 to 15 days after information from the patient's family.
Patient follow-up during trial Initial visit: for parents and patient information. Further visits (W4, W18, W24, M12): treatment administrations will be done at the CIC. Subjects will be evaluated on efficacy and safety and acceptability. Stool, urine and blood samples will be collected.

Phone visits (W11 and M9): Safety and the Acceptability questionnaire (parents) will be evaluated.
Products: donor and transplant preparation
Same administration schedule in FMT
- D1 to D4: Vancomycin (10mg/kg, 4 times a day). 1st dose in the CIC, the 3 others at home
- D4: Picoprep® treatment at home
- D5: First FMT using rectal enema (100ml = 25g of stool from donor) using Foley probe (rectal administration) in CIC
- D12: Second FMT using rectal enema (100ml = 25g of stool from donor) using Foley probe (rectal administration) in CIC
- D19: Third FMT using rectal enema (100ml = 25g of stool from donor) using Foley probe (rectal administration) in CIC

Enrollment

5 estimated patients

Sex

All

Ages

36 to 72 months old

Volunteers

No Healthy Volunteers

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