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NCT04566679: BUZIR
Butyrate in Children With IBS: Double Blind Placebo Controlled Randomized Clinical Trial
NA trial testing Dibuzin in Irritable Bowel Syndrome (IBS) in 50 participants. Status unknown.
1 January 2023
Quick facts
| Lead sponsor | University of Bari |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 21 April 2021 |
| Primary completion | 1 January 2023 |
| Estimated completion | 1 January 2023 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Dibuzin
- placebo
Conditions studied
- Irritable Bowel Syndrome (IBS) — all drugs for Irritable Bowel Syndrome (IBS) →
- Children, Only — all drugs for Children, Only →
Sponsor
University of Bari
Who can join
Adults 4 to 16, any sex, with Irritable Bowel Syndrome (IBS) or Children, Only. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
We will perform a randomized, double-blind, placebo-controlled trial to establish whether calcium butyrate relieves symptoms in children with irritable bowel syndrome (IBS). The direct effects of butyrate on inflammation and GI symptoms will be studied in children with IBS. The design used to study the effects of calcium butyrate will be a double blind randomized placebo-controlled parallel design.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Calcium butyrate efficacy in pediatric irritable bowel syndrome: Randomized placebo-controlled multiomics-based clinical trial.
Cristofori F, Calabrese FM, Iacobellis I, Santamaria M, et al · · 2025 · cited 1× · PMID 40635319 · DOI 10.1002/jpn3.70154
Verify or expand the search:
- PubMed search for NCT04566679
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Irritable Bowel Syndrome (IBS)
Currently open trials in the same condition.
- NCT07481422 — Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndro · Phase 1, PHASE2 · recruiting
- NCT07261826 — Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics · recruiting
- NCT07000227 — Mechanism of FODMAP Restriction on FGID Patients · NA · recruiting
- NCT06647043 — Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome · NA · recruiting
- NCT06668922 — Irritable Bowel Syndrome and Control Volunteers: Diet Challenge · NA · 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 NCT04566679 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 23 April 2021
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/NCT04566679.
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