RecruitingNCT07032857

Intestinal Permeability in Children With Autism Spectrum Disorder

Breaking Barriers: A Clinical Experimental Study of Intestinal Permeability in Children With Autism Spectrum Disorder


Sponsor

University of Bari

Enrollment

55 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 2 YearsMax Age: 14 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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.

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Locations(1)

University Of Bari Aldo Moro

Bari, BA, Italy

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NCT07032857


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