The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease
NCT ID: NCT04842149
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2021-05-21
2024-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bif195 capsules
The capsule will contain approximately 15\*10\^9 CFU of Bif195 per day. Excipients: Microcrystalline Cellulose 6 mg per capsule, Magnesium Stearate 1.5 mg per capsule, Maltodextrin 277.8 mg per capsule, and Sodium Ascorbate 14.7 mg per capsule.
Bif195 capsules
1 capsule daily for 8 weeks
Placebo capsules
The capsule contain only excipients: Microcrystalline Cellulose 6 mg per capsule, Magnesium Stearate 1.5 mg per capsule, Maltodextrin 277.8 mg per capsule, and Sodium Ascorbate 14.7 mg per capsule.
Placebo capsules
1 capsule daily for 8 weeks
Interventions
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Bif195 capsules
1 capsule daily for 8 weeks
Placebo capsules
1 capsule daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* Fecal calprotectin ≥ 250 ug/g
* IUS evidence of small bowel inflammation with wall thickness ≥ 4 mm
* At least 3 months af stable medical treatment
* Able to read and speak Danish
Exclusion Criteria
* Use of antibiotics, probiotics and systemic glucocorticosteroids within 4 weeks prior to inclusion
* Participation in other clinical trials within 30 days prior to inclusion
* Pregnancy, planned pregnancy or breast feeding
* Psychiatric disease
* Abuse of alcohol or drugs
18 Years
75 Years
ALL
No
Sponsors
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Chr Hansen
INDUSTRY
Hvidovre University Hospital
OTHER
Responsible Party
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Andreas Munk Petersen
Principal Investigator, MD, PhD
Principal Investigators
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Andreas M Petersen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gastrounit, Copenhagen University Hospital Hvidovre, Copenhagen
Locations
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Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, Denmark
Countries
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References
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Gronbaek IMB, Halkjaer SI, Mollerup S, Hansen EH, Paulsen SJ, Engel S, Theede K, Wilkens R, Boysen T, Petersen AM. The effects of probiotic treatment with Bifidobacterium breve, Bif195 for small intestinal Crohn's disease and the gut microbiome: results from a randomised, double-blind, placebo-controlled trial. Gut Pathog. 2025 Apr 9;17(1):19. doi: 10.1186/s13099-025-00692-6.
Other Identifiers
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H-20068527
Identifier Type: -
Identifier Source: org_study_id
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