- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00268164
Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis
May 5, 2015 updated by: Hvidovre University Hospital
The purpose of this study is to determine whether the lactic acid bacteria " Lactobacillus acidophilus (LA5) and Bifidobacterium animalis subsp.
lactis (BB12)" is effective as maintenance treatment in ulcerative colitis.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hvidovre, Denmark, 2650
- Dept. of medical gastroenterology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with ulerative colitis ording to well-known diagnostic criteria and remission for at least one month, and with at least one relapse within the last year.
Exclusion Criteria:
- Pregnancy and lactating
- Serious underlying disease other than UC
- Former gastrointestinal resections
- Medication for UC other than mesalazine
- Known allergic reactions towards compounds in the study drug.
- Expected lack of compliance due to mental state or language problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Number of patients with relapse at 12 month.
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Secondary Outcome Measures
Outcome Measure |
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Number of days to relapse.
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Presence and concentrations of the probiotic bacterial strains in stool.
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Safety and tolerance of the probiotic mixture.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Flemming Bendtsen, MD, DMSci, Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
December 21, 2005
First Submitted That Met QC Criteria
December 21, 2005
First Posted (Estimate)
December 22, 2005
Study Record Updates
Last Update Posted (Estimate)
May 6, 2015
Last Update Submitted That Met QC Criteria
May 5, 2015
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AB coul
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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