Intestinal permeability testing in children with autism
Official title: Breaking Barriers: A Clinical Experimental Study of Intestinal Permeability in Children With Autism Spectrum Disorder
Run by University of Bari · NCT07032857 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 2 Years to 14 Years |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | University of Bari Academic / other |
| Locations | 1 site (Bari, BA) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | September 30, 2025 |
| Study ends | September 30, 2025 |
| Registry record updated | June 27, 2025 |
| Trial ID | NCT07032857 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
University Of Bari Aldo Moro
Bari, Ba, Italy Recruiting
Study contacts
- Study coordinator: Ruggiero Francavilla, Prof
- Email: rfrancavilla@gmail.com
- Phone: 00390805592063
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.