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NCT04566679: BUZIR

Butyrate in Children With IBS: Double Blind Placebo Controlled Randomized Clinical Trial

Status unknown NA Last updated 23 April 2021
What this trial tests

NA trial testing Dibuzin in Irritable Bowel Syndrome (IBS) in 50 participants. Status unknown.

Timeline
21 April 2021
Primary endpoint
1 January 2023
1 January 2023

Quick facts

Lead sponsorUniversity of Bari
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment50
Start date21 April 2021
Primary completion1 January 2023
Estimated completion1 January 2023
Sites2 locations across Italy

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other recruiting trials for Irritable Bowel Syndrome (IBS)

Currently open trials in the same condition.

Other University of Bari trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing