Who is sponsoring NCT04808271?

NCT04808271 is sponsored by Hvidovre University Hospital.

What drugs are being tested in NCT04808271?

Interventions in NCT04808271: Bifidobacterium breve Bif195, Placebo.

What condition does NCT04808271 study?

NCT04808271 studies Irritable Bowel Syndrome.

Is NCT04808271 still recruiting?

NCT04808271 is currently completed. Last updated 6 July 2023.

Last reviewed 2023-07-06 · How we verify

NCT04808271

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome

Completed NA Last updated 6 July 2023

What this trial tests

NA trial testing Bifidobacterium breve Bif195 in Irritable Bowel Syndrome in 61 participants. Completed in 9 May 2023.

Timeline

16 April 2021

Primary endpoint
9 May 2023

9 May 2023

Quick facts

Lead sponsor	Hvidovre University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	61
Start date	16 April 2021
Primary completion	9 May 2023
Estimated completion	9 May 2023
Sites	2 locations across Denmark

Drugs / interventions tested

Bifidobacterium breve Bif195
Placebo

Conditions studied

Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Hvidovre University Hospital

Who can join

Adults 18 to 60, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to investigate if the probiotic Bifidobacterium breve Bif195 (Bif195) will result in improvement in clinical outcome in patients with diarrhea-predominant irritable bowel syndrome (IBS).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Eight weeks of treatment with probiotic <i>Bifidobacterium breve</i>, Bif195 lowers fatigue scores in patients with diarrhoea-predominant irritable bowel syndrome: results from a randomised, clinical trial.
Grønbæk IMB, Halkjær SI, Hansen EH, Mollerup S, et al · · 2025 · PMID 41648756 · DOI 10.3389/fnut.2025.1701341
Faecal sample storage without ethanol for up to 24 h followed by freezing performs better than storage with ethanol for shotgun metagenomic microbiome analysis in patients with inflammatory and non-inflammatory intestinal diseases and healthy controls.
Grønbæk IMB, Mollerup S, Halkjær SI, Paulsen SJ, et al · · 2024 · PMID 39548565 · DOI 10.1186/s13104-024-06999-y

Verify or expand the search:

Other recruiting trials for Irritable Bowel Syndrome

Currently open trials in the same condition.

NCT07235228 — Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients · NA · recruiting
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 Hvidovre University Hospital trials

Trials by the same sponsor.

NCT07561164 — Feasibility of a Co-designed Mobility Intervention After Hip Fracture Surgery · NA · not yet recruiting
NCT06909240 — Progressive Gait Training After First-time Deep Venous Thrombosis: Clinical Effectiveness and Involved Mecanisms (The DV · NA · recruiting
NCT07054216 — Probiotic for Infants · NA · recruiting
NCT07029334 — Effectiveness Evaluation of Social Prescribing · recruiting
NCT06789484 — Characterization of the Gastrointestinal Microbiota in Newborn Infants · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04808271 (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 Hvidovre University Hospital
Last refreshed: 6 July 2023

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/NCT04808271.

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