Autism Spectrum Disorder as a Brain-Gut-Microbiome Axis Disorder.
Virginia Saurman, Kara G Margolis, Ruth Ann Luna
https://pubmed.ncbi.nlm.nih.gov/32056091Actively Recruiting
Phase Not Applicable
Age: 3Years - 6Years
All Genders
ID06514573
Effects of a Postbiotic Supplementation on Gastrointestinal and Core Symptoms in Autism Spectrum Disorder: A Multicenter Randomized Controlled Trial
Led by Istituto Superiore di Sanità · Updated on 2025-05-02
128
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
Sponsors
I
Istituto Superiore di Sanità
Lead Sponsor
U
University of Rome Tor Vergata
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Butyrate Supplementation in Children With Autism Spectrum Disorder (ASD) and Functional Gastrointestinal Disorders
Who Can Participate
Age: 3Years - 6Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 6 years
- Both sexes
- Diagnosis of Autism Spectrum Disorder (ASD)
- Presence of functional gastrointestinal disorders (FGIDs) with a Gastrointestinal Severity Index score greater than 7 for more than 3 months
You will not qualify if you...
- Age exactly 6 years
- Uncertain diagnosis of FGIDs
- FGIDs symptoms lasting less than 3 months
- Presence of other chronic conditions such as adverse food reactions, metabolic disorders, or infections
- Malformations or chronic diseases of the gastrointestinal or urinary tracts
- Immunodeficiencies
- Diabetes
- Neurologic, cardiovascular, or autoimmune diseases
- Obesity
- Malnutrition
- Use of antibiotics or pre-/pro-/synbiotics within 6 months before enrollment
- Participation in other clinical trials within the last 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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)
Trial Site Locations
Total: 3 locations
1
Azienda Ospedaliera Universitaria Federico II
Naples, Italy, 80131
Actively Recruiting
2
Policlinico Tor Vergata Hospital
Rome, Italy, 00133
Actively Recruiting
3
Istituto Superiore di Sanità
Rome, Italy, 00161
Actively Recruiting
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Research Team
M
Maria Luisa Scattoni, Ph.D.
M
Maria Puopolo, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The Gut-Brain Axis in Autism Spectrum Disorder: A Focus on the Metalloproteases ADAM10 and ADAM17.
Yuanpeng Zheng, Tessa A Verhoeff, Paula Perez Pardo...
https://pubmed.ncbi.nlm.nih.gov/33374371Gut Microbiota Features in Young Children With Autism Spectrum Disorders.
Lorena Coretti, Lorella Paparo, Maria Pia Riccio...
https://pubmed.ncbi.nlm.nih.gov/30619212Alteration of Gut Microbiota: New Strategy for Treating Autism Spectrum Disorder.
Jiayin Liu, Zhanyuan Gao, Chuanqi Liu...
https://pubmed.ncbi.nlm.nih.gov/35309933Gut microbiota dysbiosis in functional gastrointestinal disorders: Underpinning the symptoms and pathophysiology.
Lai Wei, Rajan Singh, Seungil Ro...
https://pubmed.ncbi.nlm.nih.gov/34584964Potential beneficial effects of butyrate in intestinal and extraintestinal diseases.
Roberto Berni Canani, Margherita Di Costanzo, Ludovica Leone...
https://pubmed.ncbi.nlm.nih.gov/21472114Butyrate enhances mitochondrial function during oxidative stress in cell lines from boys with autism.
Shannon Rose, Sirish C Bennuri, Jakeira E Davis...
https://pubmed.ncbi.nlm.nih.gov/29391397Unusual repertoire of vocalizations in the BTBR T+tf/J mouse model of autism.
Maria Luisa Scattoni, Shruti U Gandhy, Laura Ricceri...
https://pubmed.ncbi.nlm.nih.gov/18728777Gut mobilization improves behavioral symptoms and modulates urinary p-cresol in chronically constipated autistic children: A prospective study.
Laura Turriziani, Arianna Ricciardello, Francesca Cucinotta...
https://pubmed.ncbi.nlm.nih.gov/34813183Gastrointestinal flora and gastrointestinal status in children with autism--comparisons to typical children and correlation with autism severity.
James B Adams, Leah J Johansen, Linda D Powell...
https://pubmed.ncbi.nlm.nih.gov/21410934