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

This study is ongoing, but not recruiting participants.

First Received: December 21, 2005 Last Updated: September 7, 2006 History of Changes

Sponsors and Collaborators:	Hvidovre University Hospital Chr.Hansen A/S, Hoersholm, Denmark
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00268164

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: 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

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

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, Hoersholm, Denmark

Investigators

Study Chair:

Flemming Bendtsen, MD, DMSci

Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark

More Information

No publications provided

Study ID Numbers:	AB coul
Study First Received:	December 21, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00268164 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative

Acidophilus
Intestinal Diseases
Gastroenteritis
Colitis
Bifidobacterium

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on September 10, 2009