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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00161148 |
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Date of registration:
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08/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Probiotics in Patients With Primary Sclerosing Cholangitis
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Scientific title:
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Probiotics in Patients With Primary Sclerosing Cholangitis and Inflammatory Bowel Disease- a Randomized Placebo-Controlled Cross-Over Trial |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00161148 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Karel v Erpecum, MD, PhD |
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Address:
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Telephone:
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+31 30 2506275 |
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Email:
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k.j.vanerpecum@azu.nl |
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Affiliation:
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Name:
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Karel v Erpecum, MD, PhD |
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Address:
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Telephone:
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+31 302506275 |
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Email:
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k.j.vanerpecum@azu.nl |
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Affiliation:
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Name:
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Karel v Erpecum, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UMC Utrecht |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of PSC based on characteristic findings on cholangiography, or based on the
triad: typical histological findings in a liver biopsy, elevated serum alkaline
phosphatase and presence of inflammatory bowel disease
- Presence of inflammatory bowel disease
- elevated serum alkaline phosphatase
- age = 18 years
- informed consent
Exclusion Criteria:
- Pregnancy
- use of probiotics within one month before the study
- use of antibiotics within one month before the study
- a history of bacterial cholangitis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Sclerosing Cholangitis
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Intervention(s)
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Drug: Probiotics
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Primary Outcome(s)
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Assessment of the effects of treatment with probiotics on serum liver tests
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Secondary Outcome(s)
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Assessment of the effects of treatment with probiotics on fatigue and pruritus
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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