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Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00268164
Recruitment Status : Terminated (Inclusion was difficult and to slow)
First Posted : December 22, 2005
Last Update Posted : May 6, 2015
Sponsor:
Collaborator:
Chr Hansen
Information provided by:
Hvidovre University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: lactobacilus acidophilus & bifidobacterium animalis/lactis Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis
Study Start Date : June 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with relapse at 12 month.

Secondary Outcome Measures :
  1. Number of days to relapse.
  2. Presence and concentrations of the probiotic bacterial strains in stool.
  3. Safety and tolerance of the probiotic mixture.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268164


Locations
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Denmark
Dept. of Medical Gastroenterology
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Chr Hansen
Investigators
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Study Chair: Flemming Bendtsen, MD, DMSci Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00268164    
Other Study ID Numbers: AB coul
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: September 2006
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases