The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease
NCT01765439 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2026-04-23
Summary
The aim of the study is to determine, whether administration of VSL#3 (Original De Simone formulation) probiotic preparation can alter the bile acid metabolism in patients with inflammatory bowel disease.
Conditions
- Crohn Disease
- Ulcerative Colitis
Interventions
- DIETARY_SUPPLEMENT
-
VSL#3 (Original De Simone formulation)
Study subjects will receive two sachets of VSL#3 probiotic (ie 2x900 billions of live bacteria) per day (one in the morning, one in the evening). The intervention period will be 6 weeks (plus or minus 5 days).
Sponsors & Collaborators
-
Iscare i.v.f., Czech Republic
collaborator UNKNOWN -
CD Investments srl
collaborator UNKNOWN -
University Of Perugia
collaborator OTHER -
University of Roma La Sapienza
collaborator OTHER -
Charles University, Czech Republic
lead OTHER
Principal Investigators
-
Martin Lenicek, MD, Ph.D. · Charles University, Czech Republic
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2027-08-31
- Completion
- 2027-12-31
Countries
- Czechia
Study Locations
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