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

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 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:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Lactobacillus Lactobacillus acidophilus

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)
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

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

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):

Wildt S, Nordgaard I, Hansen U, Brockmann E, Rumessen JJ. A randomised double-blind placebo-controlled trial with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 for maintenance of remission in ulcerative colitis. J Crohns Colitis. 2011 Apr;5(2):115-21. doi: 10.1016/j.crohns.2010.11.004. Epub 2011 Jan 8.


ClinicalTrials.gov 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 Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases	Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on July 21, 2017

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