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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Hvidovre University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Chr Hansen A/S
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00268164
First received: December 21, 2005
Last updated: September 7, 2006
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
  Eligibility
Ages Eligible for Study:   18 Years and older
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

No publications provided by Hvidovre University Hospital

Additional 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: September 7, 2006
Health Authority: Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on March 03, 2015