NCT07032857 Intestinal Permeability in Children With Autism Spectrum Disorder
| NCT ID | NCT07032857 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bari |
| Condition | Autism Spectrum Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2023-01-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07032857 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 14 Years, studying Autism Spectrum Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07032857 currently recruiting?
Yes, NCT07032857 is actively recruiting participants. Contact the research team at rfrancavilla@gmail.com for enrollment information.
Where is the NCT07032857 trial being conducted?
This trial is being conducted at Bari, Italy.
Who is sponsoring the NCT07032857 clinical trial?
NCT07032857 is sponsored by University of Bari. The trial plans to enroll 55 participants.