Actively Recruiting
Intestinal Permeability in Children With Autism Spectrum Disorder
Led by University of Bari · Updated on 2025-06-27
55
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In recent years, increasing attention has been directed toward the role of the gut-brain axis in the pathogenesis of neurodevelopmental disorders, particularly Autism Spectrum Disorder (ASD). Among the multiple contributing factors, the integrity of the intestinal barrier appears to play a crucial role. Enhanced paracellular permeability ("leaky gut") may allow luminal antigens and microbial metabolites to translocate into the systemic circulation, triggering inflammatory responses that could impact neuropsychological functioning. Several studies suggest that, although intestinal permeability is not universally altered in all individuals with ASD, there exists a subset characterized by selective epithelial dysfunction, especially associated with repetitive and stereotyped behaviors. This project aims to investigate, through a controlled sibling-based design, whether intestinal permeability indices are significantly altered in children with ASD and whether such alterations are specifically correlated with behavioral domains assessed through the ADOS instrument.
CONDITIONS
Official Title
Intestinal Permeability in Children With Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G
- Consumption of a gluten-containing diet
- Negative celiac disease serology (EMA and anti-TG2 IgA antibodies)
- Absence of IgE- or non-IgE-mediated food allergies
You will not qualify if you...
- Known neurological disorders
- Major congenital anomalies
- Severe head trauma
- Chronic gastrointestinal diseases
- Special diets (e.g., gluten-free or gluten/casein-free)
- Antibiotic or probiotic/prebiotic intake in the previous 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Of Bari Aldo Moro
Bari, BA, Italy, 70126
Actively Recruiting
Research Team
R
Ruggiero Francavilla, Prof
CONTACT
F
fernanda Cristofori, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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