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Search / Trial NCT07032857

Intestinal Permeability in Children With Autism Spectrum Disorder

Launched by UNIVERSITY OF BARI · Jun 18, 2025

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Autism Spectrum Disorders Intestinal Permeability Leaky Gut

ClinConnect Summary

This clinical trial is looking at whether children with Autism Spectrum Disorder (ASD) have differences in their gut health, specifically how "leaky" their intestines might be. The idea is that if the gut barrier is more open than usual, certain substances from the gut could enter the bloodstream and possibly affect the brain and behavior. The study will compare children with ASD to their siblings without ASD to see if there is a link between gut health and behaviors often seen in autism.

Children who might join the study need to have a confirmed diagnosis of ASD, be eating a diet that includes gluten (found in foods like bread and pasta), and not have celiac disease or food allergies. Kids with other major health issues, certain diets, or recent use of antibiotics or probiotics won’t be eligible. If selected, participants will undergo tests to measure their intestinal permeability and have their behaviors assessed. This study hopes to better understand how gut health might relate to autism symptoms, which could help guide future treatments.

Gender

ALL

Eligibility criteria

  • 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.

About University Of Bari

The University of Bari, a prestigious academic institution located in Bari, Italy, is dedicated to advancing medical research and education. With a strong emphasis on innovation and interdisciplinary collaboration, the university conducts clinical trials aimed at improving patient outcomes and contributing to the global body of medical knowledge. Leveraging its expertise in various fields of healthcare, the University of Bari fosters an environment that prioritizes ethical practices, scientific rigor, and the development of new therapeutic strategies, ultimately enhancing the quality of life for diverse patient populations.

Locations

Bari, Ba, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported