Butyrate Supplementation in Children With Autism Spectrum Disorder (ASD) and Functional Gastrointestinal Disorders

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Autism Spectrum Disorder (ASD)

In brief

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.

Key facts

Study ID

NCT06514573

Run by

Istituto Superiore di Sanità

People needed

128

Starts

2025-05-01

Expected to finish

2026-11-01

Last updated by the study team

2025-05-02

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• children aged 3-6 years
• both sexes
• ASD diagnosis and presence of FGIDs (6-item Gastrointestinal Severity Index (6-GSI) >7 from > 3 months)

You may not qualify if…

• 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 it is running

• Azienda Ospedaliera Universitaria Federico II — Naples, Italy (enrolling)
• Policlinico Tor Vergata Hospital — Rome, Italy (enrolling)
• Istituto Superiore di Sanità — Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.