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The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease: a Double-blind, Randomized, Placebo-controlled Study
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 small intestinal Crohn's disease.
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) with an incidence rate at 11/100 000 per year in Denmark. The disease can potentially affect the entire gastrointestinal tract, though the most common affected area is terminal ileum and the adjacent part of colon. CD is a result of both genetic and environmental factors together with the intestinal microbiota, however the precise etiology is unclear. A change of the intestinal microbiota with a reduced occurrence of e.g. Bacteroides species, Firmicutes and the anti-inflammatory bacteria Faecalibacterium prausnitzii is found in CD patients compared to healthy controls. Also a reduction of the mucosa-associated Bifidobacteria has been associated with the risk of mucosal inflammation. The hypothesis that an imbalance between potentially beneficial and pathogenic bacteria contribute to the pathogenesis of IBD, including CD, has led to the suggestion that manipulation of the microbiota may be an attractive target for therapeutic interventions in IBD. A new probiotic bacterium, Bifidobacterium breve Bif195 (Bif195) has been identified and has shown great effects on preventing enteropathy and ulcers on the gut mucosa in healthy volunteers given acetylsalicylic acid (13), and thereby Bif195 has also shown a potential in reducing gut permeability defects. This bacterium has not yet been investigated in CD patients.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, Denmark
Start Date
May 21, 2021
Primary Completion Date
April 30, 2024
Completion Date
November 30, 2024
Last Updated
May 30, 2025
33
ACTUAL participants
Bif195 capsules
DIETARY_SUPPLEMENT
Placebo capsules
DIETARY_SUPPLEMENT
Lead Sponsor
Hvidovre University Hospital
Collaborators
NCT07245394
NCT07089420
Data Source & Attribution
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