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

NCT07105267 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: APHP2414182025-520539-17-00
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Fecal Microbiota Transplantation (FMT)

Keywords

Austim Spectrum Disorder; FMT; gastrointestinal symptom,

Outcome Measures

Primary Outcomes (1)

• Score of the Gastrointestinal Symptoms Rating Scale (GSRS)

  Assess initial efficacy on gastrointestinal (GI) symptoms of fecal microbiota transplantation (FMT) in children (36 to 72 months) with autism spectrum disorders (ASD (FMT) The Gastrointestinal Symptoms Rating Scale (GSRS) uses 15 items rated on a 7-point scale to assess gastrointestinal symptom severity, with total scores ranging from 15 (no symptoms) to 105 (very severe symptoms). Higher GSRS scores indicate more severe symptoms and a worse gastrointestinal outcome.

  Week 18

Secondary Outcomes (4)

• Score of Vineland Adaptative Behavior Composite 3 scale

  Day 0, Week 4, Week 18, Week 24, Month 12

• Score of Pediatric Adverse Event Rating Scale

  Day 0, Day 5, Week 4, Week 18, Week 24, Month 12

• Tolerability: Score of bristol Stool form

  Day 0, Week 4, Week 18, Week 24, Month12

• Score of Pediatric Quality of Life Inventory

  Day 0, Week 18, Month 12

Study Arms (1)

Felictia Arm

EXPERIMENTAL

FMT

Drug: FMT Protocol

Interventions

FMT Protocol DRUG

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

Felictia Arm

Eligibility Criteria

• Age: 36 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Severe intellectual deficit (IQ\<30) or another uncontrolled comorbidity (e.g. epilepsy)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation initiative autisme: collaborator
• Fondation Erie: collaborator
• Biocodex microbiota fondation: collaborator

Study Sites (1)

Robert Debré Hospital

Paris, Ap-hp / DRCI, 75019, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

FMT protocol

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Pierre ELLUL, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre ELLUL, MD

CONTACT

0033140034635; pierre.ellul@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

FR (1)