Effects of a Postbiotic Supplementation on Gastrointestinal and Core Symptoms in Autism Spectrum Disorder: A Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 6
Healthy Volunteers: f
View:

• children aged 3-6 years

• both sexes

• ASD diagnosis and presence of FGIDs (6-item Gastrointestinal Severity Index (6-GSI) \>7 from \> 3 months)

Locations
Other Locations
Italy
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Naples
Istituto Superiore di Sanità
RECRUITING
Rome
Policlinico Tor Vergata Hospital
RECRUITING
Rome
Contact Information
Primary
Maria Luisa Scattoni, Ph.D.
marialuisa.scattoni@iss.it
+39 0649903104
Backup
Maria Puopolo, MSc
maria.puopolo@iss.it
+39 0649903087
Time Frame
Start Date: 2025-05
Estimated Completion Date: 2026-11
Participants
Target number of participants: 128
Treatments
Experimental: Butyrate
The butyrate groups (butyrate \<=20 kg, butyrate \>20 kg) will receive oral sodium butyrate (dose of 20 mg/kg body weight/daily in sachets, up to 800 mg/day maximum dose) plus ASD standard care.
Placebo_comparator: Placebo
The placebo groups (placebo \<=20 kg, placebo \>20 kg) will receive placebo (cornstarch) at the same dose and time plus ASD standard care.
Related Therapeutic Areas
Sponsors
Collaborators: Federico II University, University of Rome Tor Vergata
Leads: Istituto Superiore di Sanità

This content was sourced from clinicaltrials.gov