Status:
COMPLETED
The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
Chr Hansen
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-60 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 diarrhea-predominant irritable bowel ...
Detailed Description
IBS is the most frequently diagnosed gastrointestinal disease and also the most common cause of referrals to gastroenterology departments in Denmark. The possibilities for treatment for IBS are limit...
Eligibility Criteria
Inclusion
- Diagnosed with IBS-D defined as more than one-fourth (25%) of bowel movements with Bristol Stool Scale Types 6-7 and less than one-fourth (25%) with Types 1-2
- Fulfill Rome IV diagnostic criteria for IBS
- Moderate to severe disease activity (IBS-SSS ≥175)
- Able to read and speak Danish
- Normal colonoscopy (performed within 1 year) if the patient had blood in stool
Exclusion
- Other chronic gastro intestinal diseases including lactose intolerance and coeliac disease
- Fecal calprotectin ≥50 mg/kg
- Fecal sample positive for enteropathogenic microorganisms
- Surgical interventions in the GI region (except for appendectomy, hernia repair, cholecystectomy and gynecological and urological procedures)
- Psychiatric disorder
- Abuse of alcohol or drugs
- Medications except birth control pills, hormone supplements, allergies/asthma agents, blood pressure and cholesterol-lowering agents, proton pump inhibitors and non-prescription medicines; abnormal colonoscopy findings
- Pregnancy, planned pregnancy or breastfeeding females
- Ingestion of probiotics or antibiotics \<4 weeks before the inclusion
- Abnormal screening biochemistry
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04808271
Start Date
April 16 2021
End Date
May 9 2023
Last Update
July 6 2023
Active Locations (2)
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1
Hvidovre Hospital, Copenhagen University
Hvidovre, Copenhagen, Denmark, 2650
2
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650