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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT01765439
• Date of registration: 07/01/2013
• Prospective Registration: Yes
• Primary sponsor: Charles University, Czech Republic
• Public title: The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease
• Scientific title: The Effect of VSL#3 (Original De Simone Formulation) Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease
• Date of first enrolment: February 2014
• Target sample size: 79
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT01765439
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Czech Republic, Czechia

Contacts

• Name: Martin Lenicek, MD, Ph.D.
• Affiliation: Charles University, Czech Republic

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Crohn Disease

Intervention(s)

Dietary Supplement: VSL#3 (Original De Simone formulation)

Primary Outcome(s)

Alteration in the rate of bile acid synthesis [Time Frame: Baseline and 6 weeks (plus or minus 5 days)]

Secondary Outcome(s)

Change of a metabolomic profile in urine [Time Frame: Baseline and 6 weeks (plus or minus 5 days).]

Change of the spectrum of bile acids in stools and plasma [Time Frame: Baseline and 6 weeks (plus or minus 5 days).]

Secondary ID(s)

VSL#3-2013-CR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Iscare i.v.f., Czech Republic

University of Roma La Sapienza

CD Investments srl

University Of Perugia