NCT06514573Recruiting
Butyrate Supplementation in Children With Autism Spectrum Disorder (ASD) and Functional Gastrointestinal Disorders
Effects of a Postbiotic Supplementation on Gastrointestinal and Core Symptoms in Autism Spectrum Disorder: A Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Autism spectrum disorder (ASD) is a neurodevelopmental condition occurring in 1:77 Italian children. Several comorbidities are reported, including functional gastrointestinal disorders (FGIDs) present in up to 70% of patients. FGIDs are disorders resulting from a combination of symptoms affecting motility, hypersensitivity, and other functions, which are not caused by anatomic or organic origin and that impact the severity of ASD core symptoms and complicate the clinical management of ASD children, especially those who are non-verbal. Evidence reports gut microbiome (GM) remodelling in ASD children, and postbiotic butyrate, a GM-derived metabolite, attenuates FGIDs in children and restores social behavior in ASD mouse models. Clinical data on butyrate effects in ASD are still scanty. The present study investigates the therapeutic effects of a 16-week oral postbiotic supplementation on clinical/behavioral profiles, gastrointestinal disturbances, gut microbiome, and immune and inflammatory biomarkers in peripheral blood and fecal samples in children with ASD and FGIDs. Using the Machine Learning (ML) approach, a subset of artificial intelligence, this study also aims to identify predictive factors implicated in the effect of the postbiotic supplementation on FGIDs, important for prevention through modulation of the microbiota. The investigators expect that treating FGIDs will have an impact on the behavioral and core symptoms of ASD and the quality of life of children and their families.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 26 Jun 2024
- Start date
- May 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- Istituto Superiore di Sanità
- Diseases
- Autism
- NCT number
- NCT06514573
What you commit to
- Study type: Interventional
- Planned participants: 128
- From May 2025 to the primary completion date, Jul 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- concomitant presence of other chronic condition (adverse food reactions, metabolic disorders, infections)
- antibiotics and/or pre-/pro-/synbiotics use 6 months prior to enrollment
Other illness
- malformation and Gi or urinary tracts chronic diseases
- diabetes
- neurologic/cardiovascular/autoimmune diseases
Age
- age 6 years
Other
- uncertain FGIDs diagnoses
- FGIDs symptoms duration \<3 months
- immunodeficiencies
- obesity
- malnutrition
- last 12 months participation into other clinical trials
Who the study is looking for
- children aged 3-6 years
- both sexes
- ASD diagnosis and presence of FGIDs (6-item Gastrointestinal Severity Index (6-GSI) \>7 from \> 3 months)
Age in the registry: 3 years to 6 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Istituto Superiore di Sanità Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Policlinico Tor Vergata Hospital Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.