Intestinal Permeability in Children With Autism Spectrum Disorder
ConditionAutism Spectrum Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-14
SponsorUniversity of Bari
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known neurological disorders.
Major congenital anomalies.
Severe head trauma.
Chronic gastrointestinal diseases.
Trial population
Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
55 Participants
are grouped into 2 trial groupsGroup A: Autism spectrum disorders
Group B: Sibilings
Trial outcomes
Primary outcomes
1
intestinal permeability
La/Ma ratio and the recovery of specific sugars (lactulose, mannitol, sucrose, sucralose).
Time frame
baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov