NCT04842149Completed
The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease
The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease: a Double-blind, Randomized, Placebo-controlled Study
Source: ClinicalTrials.gov · Last updated 30 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 8 Apr 2021
- Start date
- 21 May 2021
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Hvidovre University Hospital
- Diseases
- Crohn's disease
- NCT number
- NCT04842149
What you commit to
- Study type: Interventional
- Participants enrolled: 33
- From 21 May 2021 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics, probiotics and systemic glucocorticosteroids within 4 weeks prior to inclusion
- Participation in other clinical trials within 30 days prior to inclusion
- Abuse of alcohol or drugs
Other illness
- Psychiatric disease
Other
- Positive rectal swab for pathogenic microorganisms
- Pregnancy, planned pregnancy or breast feeding
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastrounit, Copenhagen University Hospital Hvidovre Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.