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

This study has been terminated.
(Inclusion was difficult and to slow)
Chr Hansen
Information provided by:
Hvidovre University Hospital Identifier:
First received: December 21, 2005
Last updated: May 5, 2015
Last verified: September 2006
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 Intervention Phase
Ulcerative Colitis
Drug: lactobacilus acidophilus & bifidobacterium animalis/lactis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Number of patients with relapse at 12 month.

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

Estimated Enrollment: 48
Study Start Date: June 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

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

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
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Please refer to this study by its identifier: NCT00268164

Dept. of Medical Gastroenterology
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Chr Hansen
Study Chair: Flemming Bendtsen, MD, DMSci Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00268164     History of Changes
Other Study ID Numbers: AB coul
Study First Received: December 21, 2005
Last Updated: May 5, 2015

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases processed this record on May 25, 2017