Trials / Completed
CompletedNCT04808271
The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome
The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Hvidovre University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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 syndrome (IBS).
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 limited. Treatment strategies that involve the microbiota provide symptom relief in some IBS patients. Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls. Probiotic interventions has shown promising results, but it currently remains unknown which probiotics are effective and which are not. 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, and thereby Bif195 has also shown a potential in reducing gut permeability defects. This bacterium has not yet been investigated in IBS patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Bifidobacterium breve Bif195 | 1 capsule daily for 8 weeks |
| DIETARY_SUPPLEMENT | Placebo | 1 capsule daily for 8 weeks |
Timeline
- Start date
- 2021-04-16
- Primary completion
- 2023-05-09
- Completion
- 2023-05-09
- First posted
- 2021-03-22
- Last updated
- 2023-07-06
Locations
2 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04808271. Inclusion in this directory is not an endorsement.