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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
University Of Bari Aldo Moro
RECRUITING
Bari
Contact Information
Primary
Ruggiero Francavilla, Prof
rfrancavilla@gmail.com
00390805592063
Backup
fernanda Cristofori, MD
fernandacristofori@gmail.com
00393384176598
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 55
Treatments
Autism spectrum disorders
Intestinal Permeability Assessment
Sibilings
Intestinal Permenability Assessmnt
Related Therapeutic Areas
Sponsors
Leads: University of Bari

This content was sourced from clinicaltrials.gov