Butyrate supplementation for children with autism and gut issues
Effects of a Postbiotic Supplementation on Gastrointestinal and Core Symptoms in Autism Spectrum Disorder: A Multicenter Randomized Controlled Trial
This study is testing if giving sodium butyrate to young children with autism and gut problems can help improve their behavior and stomach issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 3 Years to 6 Years |
| Sex | All |
| Sponsor | Istituto Superiore di Sanità Academic / other |
| Locations | 3 sites (Naples and 2 other locations) |
| Trial ID | NCT06514573 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a 16-week oral supplementation of sodium butyrate in children aged 3-6 years diagnosed with Autism Spectrum Disorder (ASD) and functional gastrointestinal disorders (FGIDs). The research aims to assess improvements in clinical and behavioral profiles, gastrointestinal symptoms, gut microbiome composition, and immune responses. By targeting the gut-brain axis and utilizing postbiotics, the study seeks to provide a novel intervention for managing ASD symptoms exacerbated by gastrointestinal issues. The trial includes a placebo group for comparison to ensure the validity of the results.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3-6 years with a confirmed diagnosis of ASD and FGIDs lasting more than three months.
Not a fit: Patients who are older than 6 years or have uncertain FGIDs diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve gastrointestinal symptoms and behavioral outcomes in children with ASD.
How similar studies have performed: While there is limited clinical data on butyrate effects in ASD, emerging evidence suggests potential benefits from similar interventions targeting gut health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * children aged 3-6 years * both sexes * ASD diagnosis and presence of FGIDs (6-item Gastrointestinal Severity Index (6-GSI) \>7 from \> 3 months) Exclusion Criteria: * age 6 years * uncertain FGIDs diagnoses * FGIDs symptoms duration \<3 months * concomitant presence of other chronic condition (adverse food reactions, metabolic disorders, infections) * malformation and Gi or urinary tracts chronic diseases * immunodeficiencies * diabetes * neurologic/cardiovascular/autoimmune diseases * obesity * malnutrition * antibiotics and/or pre-/pro-/synbiotics use 6 months prior to enrollment * last 12 months participation into other clinical trials
Where this trial is running
Naples and 2 other locations
- Azienda Ospedaliera Universitaria Federico II — Naples, Italy (Recruiting)
- Policlinico Tor Vergata Hospital — Rome, Italy (Recruiting)
- Istituto Superiore di Sanità — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Luisa Scattoni, Ph.D. — Istituto Superiore di Sanità
- Study coordinator: Maria Luisa Scattoni, Ph.D.
- Email: marialuisa.scattoni@iss.it
- Phone: +39 0649903104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.