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Clinical Trials in Czechia / NCT01765439
Active, not recruiting Not applicable

The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease

NCT01765439 · tracked via the Priya Life Science Czechia tracker
Sponsor
Charles University, Czech Republic
Phase
Not applicable
Started
2014-02
Last updated
2026-04-23

Condition(s) studied

Crohn DiseaseUlcerative Colitis

Investigational drug(s) / intervention(s)

VSL#3 (Original De Simone formulation)

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).

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 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) Exclusion Criteria: * use of bile acids * use of bile acids sequestrants * use of farnesoid X receptor agonists/antagonists * recent colonoscopy(less than 1 month before inclusion) * diabetes

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Iscare I.V.F. Prague Czechia

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Other trials for the same condition

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A Study to Investigate the Efficacy and Safety of Brivekimig in Adult Participants With Ulcerative Colitis Active, not recruiting
Gluten-free Diet in PSC and IBD Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01765439 on ClinicalTrials.gov ↗ ← All trials in Czechia