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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)
Sponsor:
Collaborator:
Chr Hansen A/S
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00268164
First received: December 21, 2005
Last updated: May 5, 2015
Last verified: September 2006
History of Changes
  Purpose
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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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)
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268164

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00268164     History of Changes
Other Study ID Numbers: AB coul 
Study First Received: December 21, 2005
Last Updated: May 5, 2015
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on September 28, 2016