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NCT07032857: IP-ASD
Intestinal Permeability in Children With Autism Spectrum Disorder
trial in Autism Spectrum Disorders in 55 participants. Currently enrolling.
30 September 2025
Quick facts
| Lead sponsor | University of Bari |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 55 |
| Start date | 1 January 2023 |
| Primary completion | 30 September 2025 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across Italy |
Conditions studied
- Autism Spectrum Disorders — all drugs for Autism Spectrum Disorders →
Sponsor
University of Bari
Who can join
Adults 2 to 14, any sex, with Autism Spectrum Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07032857
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Autism Spectrum Disorders
Currently open trials in the same condition.
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- NCT06848959 — Development and Application of a Diagnosis and Treatment System for Children's Brain Diseases Based on Knowledge Graphs · recruiting
- NCT05910502 — Project AFECT (Autism Family Empowerment Coaching and Training Program) · NA · active not recruiting
Other University of Bari trials
Trials by the same sponsor.
- NCT06854133 — Factors of Effectiveness in Italian Forensic Treatment · not yet recruiting
- NCT07125625 — Probiotic Mixture (L. Rhamnosus GG and L. Plantarum 299V) In Pediatric Irritable Bowel Syndrome · NA · not yet recruiting
- NCT07036627 — Intestinal Microbiota After PPI Treatment · not yet recruiting
- NCT07050693 — Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections. · NA · recruiting
- NCT06719999 — PRIMA Project- Box for Heath and Tradition (B4HT) · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07032857 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Bari
- Last refreshed: 27 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07032857.
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