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NCT Number: NCT07105267

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Fecal Microbiota Transplantation (FMT) Mental Disorders Neurodevelopmental Disorders

Age range

36 month–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FMT Protocol

Drug

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

Primary outcomes

  1. Score of the Gastrointestinal Symptoms Rating Scale (GSRS)

    Time frame: Week 18

    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.

Secondary outcomes

  1. Score of Vineland Adaptative Behavior Composite 3 scale

    Time frame: Day 0, Week 4, Week 18, Week 24, Month 12

    Estimate the effect of FMT on autistic core symptoms and global functioning (socio adaptivecapacities, social cognition, repetitive and stereotyped behaviors) The Vineland Adaptive Behavior Scales (VABS) standard scores for each domain and the overall Adaptive Behavior Composite (ABC) range from 20 (minimum) to 160 (maximum), with a mean of 100 and a standard deviation of 15. Higher Vineland scores indicate better adaptive functioning and more positive outcomes, whereas lower scores reflect greater impairment in adaptive behavior

  2. Score of Pediatric Adverse Event Rating Scale

    Time frame: Day 0, Day 5, Week 4, Week 18, Week 24, Month 12

    FMT side effects (antibiotic therapy, GM transplantation from a healthy donor): Pediatric Adverse Event Rating Scale [evaluated by the investigator at day (D) 0, D5, W4, W18, W24, M12The Pediatric Adverse Event Rating Scale (PAERS) uses a combined score for each symptom that ranges from 0 (no symptom) to 5 (most severe/extreme symptom with impairment), based on symptom presence, functional impairment, and severity. Higher PAERS scores indicate more severe or impactful adverse events, representing a worse outcome]

  3. Tolerability: Score of bristol Stool form

    Time frame: Day 0, Week 4, Week 18, Week 24, Month12

    Estimate FMT tolerability: completion of the FMT process and acceptability questionnaire (parents)

  4. Score of Pediatric Quality of Life Inventory

    Time frame: Day 0, Week 18, Month 12

    Estimate FMT impact on children and parent's quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre ELLUL, MD

CONTACT

[email protected]

0033140034635

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Biocodex microbiota fondation
  • Fondation Erie
  • Fondation initiative autisme

Registry information

Official study title

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

Acronym: FELICITA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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