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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Score of the Gastrointestinal Symptoms Rating Scale (GSRS) — 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.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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