NCT07032857Recruiting
Intestinal Permeability in Children With Autism Spectrum Disorder
Breaking Barriers: A Clinical Experimental Study of Intestinal Permeability in Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 55 (estimated)
- First submitted
- 10 Jun 2025
- Start date
- 1 Jan 2023
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- University of Bari
- Diseases
- Autism
- NCT number
- NCT07032857
What you commit to
- Study type: Observational
- Planned participants: 55
- From 1 Jan 2023 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antibiotic or probiotic/prebiotic intake in the previous 4 weeks.
Other illness
- Known neurological disorders.
- Chronic gastrointestinal diseases.
Other
- Major congenital anomalies.
- Severe head trauma.
- Special diets (e.g., gluten-free or gluten/casein-free).
Criteria the registry did not label
- 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.
Age in the registry: 2 years to 14 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Bari Aldo Moro Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.