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

NCT ID: NCT07105267

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-04-01

Brief Summary

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.

Detailed Description

1. Screening :

Screening will be done in ASD units of child psychiatry departments of Robert Debré

2. Information of patients and their families Information will be delivered in the child psychiatry department of Robert Debré hospital.

3. 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.

4. 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.

5. Products: donor and transplant preparation

6. 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

Conditions

Autism Spectrum Disorder; Fecal Microbiota Transplantation (FMT)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Felictia Arm

FMT

Group Type: EXPERIMENTAL

FMT Protocol

Intervention Type: DRUG

FMT protocol Samples (urine, blood, stool) collection Psychological examination Pediatric quality of life Scale Bristol Stool form Scale

Interventions

FMT Protocol

FMT protocol Samples (urine, blood, stool) collection Psychological examination Pediatric quality of life Scale Bristol Stool form Scale

Intervention Type: DRUG

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

• Minimum Eligible Age: 36 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation initiative autisme

UNKNOWN

Sponsor Role: collaborator

Fondation Erie

UNKNOWN

Sponsor Role: collaborator

Biocodex microbiota fondation

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre ELLUL, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Robert Debré Hospital

Paris, Ap-hp / DRCI, France

Countries

France

Central Contacts

Pierre ELLUL, MD

Role: CONTACT

pierre.ellul@aphp.fr

0033140034635

Facility Contacts

Pierre ELLUL, MD

Role: primary

pierre.ellul@aphp.fr

0033140031635

Other Identifiers

2025-520539-17-00

Identifier Type: CTIS

Identifier Source: secondary_id

APHP241418

Identifier Type: -

Identifier Source: org_study_id