Intestinal permeability testing in children with autism
Breaking Barriers: A Clinical Experimental Study of Intestinal Permeability in Children With Autism Spectrum Disorder
University of Bari · NCT07032857
This tests whether children with autism have a leakier gut than their unaffected siblings by having them drink a sugar mix and collecting urine for measurement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 2 Years to 14 Years |
| Sex | All |
| Sponsor | University of Bari (other) |
| Locations | 1 site (Bari, BA) |
| Trial ID | NCT07032857 on ClinicalTrials.gov |
What this trial studies
This is a single-center, sibling-controlled observational case-control study enrolling children aged 2–14 with ASD and their neurotypical siblings. Participants fast and then take an oral sugar cocktail (lactulose, mannitol, sucrose, sucralose) with all urine collected for 6 hours to calculate lactulose/mannitol ratios and individual sugar recoveries. The study also measures fecal calprotectin to screen for intestinal inflammation and correlates permeability markers with ADOS-derived behavioral dimensions, with special attention to repetitive and stereotyped behaviors. Exclusion criteria include special diets (e.g., gluten-free), recent antibiotics or probiotics, celiac disease, major neurological or chronic GI disorders.
Who should consider this trial
Good fit: Children aged 2–14 with a clinical ASD diagnosis confirmed by ADOS-G, consuming a gluten-containing diet, with negative celiac serology and no IgE or non-IgE food allergies are ideal candidates.
Not a fit: Children with celiac disease, on special diets (for example gluten-free or casein-free), recent antibiotic/probiotic use, chronic gastrointestinal disease, or major neurological conditions may not be eligible or likely to benefit from this protocol.
Why it matters
Potential benefit: If findings confirm a subgroup with altered intestinal permeability, this could help identify a biological marker to explain symptoms in some children with ASD and guide targeted gut-directed approaches.
How similar studies have performed: Prior studies have reported altered intestinal permeability in a subset of individuals with ASD but results are inconsistent, and the sibling-controlled design here is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bari, BA
- University Of Bari Aldo Moro — Bari, BA, Italy (RECRUITING)
Study contacts
- Study coordinator: Ruggiero Francavilla, Prof
- Email: rfrancavilla@gmail.com
- Phone: 00390805592063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorders, autism spectrum Disorders, Intestinal permeability, Leaky gut