NCT01765439Active, not recruiting
The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease
The Effect of VSL#3 (Original De Simone Formulation) Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 79 (actual)
- First submitted
- 7 Jan 2013
- Start date
- 1 Feb 2014
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Charles University, Czech Republic
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT01765439
What you commit to
- Study type: Interventional
- Participants enrolled: 79
- From 1 Feb 2014 to the primary completion date, 31 Aug 2027
- 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
- recent colonoscopy(less than 1 month before inclusion)
Other illness
- diabetes
Other
- use of bile acids
- use of bile acids sequestrants
- use of farnesoid X receptor agonists/antagonists
Who the study is looking for
- Arm CD resected
- confirmed diagnosis of Crohn´s disease (at least 6 months)
- history of single resection of terminal ileum (at least 6 months before inclusion)
- maximum length of resected ileum is 60 cm
- no signs of disease activity (clinical, endoscopical, laboratory)
- stable medication
- Arm UC unoperated
- confirmed diagnosis of ulcerative colitis (at least 6 months)
- no signs of disease activity (clinical, endoscopical, laboratory)
- stable medication
- Arm UC IPAA
- confirmed diagnosis of ulcerative colitis (at least 6 months)
- proctocolectomy and IPAA (at least 3 months before inclusion)
- no signs of disease activity (clinical, endoscopical, laboratory)
- stable medication
- Arm Healthy volunteers
- no signs of gastrointestinal disorder
- initial laboratory examination within normal range (blood count, liver function tests, C-reactive protein, Fe, ferritin, fecal calprotectin)
Sex: All · Accepts 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 |
|---|---|---|---|
| Iscare I.V.F. Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.