Intestinal Permeability in Children With Autism Spectrum Disorder

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-14
SponsorUniversity of Bari

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Known neurological disorders.

Major congenital anomalies.

Severe head trauma.

Chronic gastrointestinal diseases.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

55 Participants
are grouped into 2 trial groups

Sponsors and collaborators