Status:
RECRUITING
Butyrate Supplementation in Children With Autism Spectrum Disorder (ASD) and Functional Gastrointestinal Disorders
Lead Sponsor:
Istituto Superiore di Sanità
Collaborating Sponsors:
University of Rome Tor Vergata
Federico II University
Conditions:
Autism Spectrum Disorder (ASD)
Eligibility:
All Genders
3-6 years
Phase:
NA
Brief 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...
Detailed Description
ASD is a heterogeneous group of neurodevelopmental disorders with complex multifactorial etiologies requiring personalized, timely, and evidence-based interventions to improve the lives of children an...
Eligibility Criteria
Inclusion
- children aged 3-6 years
- both sexes
- ASD diagnosis and presence of FGIDs (6-item Gastrointestinal Severity Index (6-GSI) \>7 from \> 3 months)
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06514573
Start Date
May 1 2025
End Date
November 1 2026
Last Update
May 2 2025
Active Locations (3)
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1
Azienda Ospedaliera Universitaria Federico II
Naples, Italy, 80131
2
Policlinico Tor Vergata Hospital
Rome, Italy, 00133
3
Istituto Superiore di Sanità
Rome, Italy, 00161