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Tracking Information | |||||
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First Received Date † | December 21, 2005 | ||||
Last Updated Date | September 7, 2006 | ||||
Start Date † | June 2004 | ||||
Current Primary Outcome Measures † |
Number of patients with relapse at 12 month. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00268164 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis | ||||
Official Title † | Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Ulcerative Colitis | ||||
Intervention † | Drug: lactobacilus acidophilus & bifidobacterium animalis/lactis | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 48 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Denmark | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00268164 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Hvidovre University Hospital | ||||
Collaborators †† | Chr.Hansen A/S, Hoersholm, Denmark | ||||
Investigators † |
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Information Provided By | Hvidovre University Hospital | ||||
Verification Date | September 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |