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Gut Barrier Permeability Tested in Children With Autism Spectrum Disorder

Compares gut lining permeability in children with autism and their siblings, aged 2 to 14.

Plain-language title generated from the registry record
Registry title: Intestinal Permeability in Children With Autism Spectrum Disorder

Key facts

Where
Bari, ItalySee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 14 years old?

Source: NCT07032857, who can take part

Where in Italy

  • University Of Bari Aldo MoroBari, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Bari
Trial code
NCT07032857
Record updated
27 June 2025
Original description
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.Read full original descriptionShow less

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

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.

Exclusion: Antibiotic or probiotic/prebiotic intake in the previous 4 weeks; Known neurological disorders; Chronic gastrointestinal diseases; Major congenital anomalies; Severe head trauma; Special diets (e.g., gluten-free or gluten/casein-free).

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.

ClinicalTrials.gov NCT07032857