Intestinal Permeability in Children With Autism Spectrum Disorder
IP-ASD
Breaking Barriers: A Clinical Experimental Study of Intestinal Permeability in Children With Autism Spectrum Disorder
1 other identifier
observational
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 10, 2025
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedJune 27, 2025
June 1, 2025
2.7 years
June 10, 2025
June 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intestinal permeability
La/Ma ratio and the recovery of specific sugars (lactulose, mannitol, sucrose, sucralose).
baseline
Study Arms (2)
Autism spectrum disorders
Intestinal Permeability Assessment
Sibilings
Intestinal Permenability Assessmnt
Eligibility Criteria
Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Of Bari Aldo Moro
Bari, BA, 70126, Italy
Biospecimen
24hr Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
June 10, 2025
First Posted
June 24, 2025
Study Start
January 1, 2023
Primary Completion
September 30, 2025
Study Completion
September 30, 2025
Last Updated
June 27, 2025
Record last verified: 2025-06