The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammato… (NCT01765439) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease
Czechia79 participantsStarted 2014-02
Plain-language 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.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Alteration in the rate of bile acid synthesis
Timeframe: Baseline and 6 weeks (plus or minus 5 days)