Intestinal Permeability in Children With Autism Spectrum Disorder

Recruiting now

Conditions studied: Autism Spectrum Disorders

In brief

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.

Key facts

Study ID

NCT07032857

Run by

University of Bari

People needed

55

Starts

2023-01-01

Expected to finish

2025-09-30

Last updated by the study team

2025-06-27

Who can join

Age: 2 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• University Of Bari Aldo Moro — Bari, BA, Italy (enrolling)

Full record on ClinicalTrials.gov

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