Status:
COMPLETED
The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
Chr Hansen
Conditions:
Crohn Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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.
Detailed Description
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, thou...
Eligibility Criteria
Inclusion
- Diagnosed with small intestinal CD
- 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
- Positive rectal swab for pathogenic microorganisms
- 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
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04842149
Start Date
May 21 2021
End Date
November 30 2024
Last Update
May 30 2025
Active Locations (1)
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1
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, Denmark, 2650