Intestinal Permeability in Children With Autism Spectrum Disorder

NCT07032857 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Bari

Phase

Observational

Started

2023-01-01

Last updated

2025-06-27

Condition(s) studied

Autism Spectrum Disorders

Study summary

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.

Eligibility

Sex

ALL

Min age

2 Years

Max age

14 Years

Healthy volunteers

* 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

intestinal permeability — baseline
La/Ma ratio and the recovery of specific sugars (lactulose, mannitol, sucrose, sucralose).

Trial sites (1)

Facility	City	Region	Status
University Of Bari Aldo Moro	Bari	BA	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07032857 on ClinicalTrials.gov ↗ ← All trials in Italy