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NCT06123234
Randomised Double-blind Active vs. Placebo Clinical Trial on the Effect of a Food Supplement on IBS in Children
NA trial testing Verum in Irritable Bowel Syndrome in 128 participants. Status unknown.
1 April 2025
Quick facts
| Lead sponsor | Azienda Ospedaliera Universitaria Policlinico "G. Martino" |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 128 |
| Start date | 1 April 2023 |
| Primary completion | 1 April 2025 |
| Estimated completion | 1 April 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Verum — full drug profile →
- Placebo
Conditions studied
- Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
Sponsor
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Who can join
Adults 3 to 17, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to test a food supplement in children of 3-17 years with IBS. The main questions it aims to answer are: * Is the tested supplement able to improve and/or reduce IBS-related symptoms? * After administration of the food supplement, how does the state of intestinal inflammation improve? * Is the gut microbiota modified? Participants will take the food supplement every day for 2 months. After 30 days and after 60 days, they will be visited from the gastroenterologist. * They have to fill in the questionnaire and the symptom's diary weekly and deliver it to the gastroenterologist during the visits * At the first visit, they will collect the faecal sample for the analysis of inflammatory markers and gut microbiota * After 30 days, they will collect the faecal sample for the analysis of inflammatory markers * After 60 days, they will collect the faecal sample for the analysis of gut microbiota Researchers will compare with placebo to see if the product is effective.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06123234
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Verum
Trials testing the same drug.
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- NCT05472285 — Evaluation of the Effects of a Food Supplementation on the Improvement of Cognitive Functions in Healthy Seniors · NA · completed
- NCT05098249 — Ferric Carboxymaltose With or Without Phosphate Substitution for the Treatment of Iron Deficiency or Iron Deficiency Ane · Phase 4 · completed
Other recruiting trials for Irritable Bowel Syndrome
Currently open trials in the same condition.
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- NCT07421011 — Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 · Phase 1 · recruiting
- NCT07360938 — Drug Interaction Potential of Pro-Inflammatory Conditions · recruiting
- NCT06788444 — Efficacy of Esketamine for Patients With Irritable Bowel Syndrome · NA · recruiting
- NCT07484412 — Efficacy and Safety of Encapsulated Bifidobacterium Longum BBH016 in Subjects With Lower Gastrointestinal Symptoms · NA · active not recruiting
Other Azienda Ospedaliera Universitaria Policlinico "G. Martino" trials
Trials by the same sponsor.
- NCT07017244 — Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics · NA · not yet recruiting
- NCT05903976 — De-escalating Antiplatelet Therapy to Assess Platelet Reactivity and Outcomes in High Bleeding Risk Patients With Recent · Phase 3 · unknown
- NCT06123559 — Physical Exercise, Motor Activity and Depression in Post-mastectomy Pain Syndrome · completed
- NCT06218225 — Effect of an Immune-boosting Food Supplement on the Severity and Frequency of Pediatric Respiratory Tract Infections · NA · completed
- NCT05713786 — Physical Exercise, Motor Activity and Post-mastectomy Pain Syndrome. · completed
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 NCT06123234 (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 Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Last refreshed: 16 July 2024
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/NCT06123234.
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