Autism Spectrum Disorder as a Brain-Gut-Microbiome Axis Disorder.
Virginia Saurman, Kara G Margolis, Ruth Ann Luna
https://pubmed.ncbi.nlm.nih.gov/32056091/Actively Recruiting
Led by Istituto Superiore di Sanità · Updated on 2025-05-02
128
Participants Needed
3
Research Sites
17 weeks
Total Duration
Researchers are evaluating the effects of a 16-week oral postbiotic supplementation, specifically sodium butyrate, on children aged 3 to 6 years with Autism Spectrum Disorder ASD who also have functional gastrointestinal disorders FGIDs. ASD is a complex neurodevelopmental condition often accompanied by FGIDs, which worsen ASD symptoms and complicate management, especially in non-verbal children. This study aims to assess how treating FGIDs may impact the behavioral and core symptoms of ASD, while also identifying factors that predict response to treatment using artificial intelligence techniques.
CONDITIONS
Butyrate Supplementation in Children With Autism Spectrum Disorder (ASD) and Functional Gastrointestinal Disorders
M
Maria Luisa Scattoni, Ph.D.
M
Maria Puopolo, MSc
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Istituto Superiore di Sanità
Lead Sponsor
University of Rome Tor Vergata
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive daily oral supplementation of either sodium butyrate or placebo for 16 weeks to evaluate its effects on gastrointestinal and behavioral symptoms in children with ASD and FGIDs.
1 baseline visit and 1 follow-up visit
Duration - 4 months after treatment ends
Participants are asked to complete questionnaires to assess the long-term effects of the supplementation without additional blood or fecal sampling.
1 follow-up visit (questionnaire only)
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/34813183/Istituto Superiore di Sanità
Lead Sponsor
University of Rome Tor Vergata
Collaborating Sponsor