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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 21, 2005

Last Updated Date

September 7, 2006

Start Date ^†

June 2004

Current Primary Outcome Measures ^†

Number of patients with relapse at 12 month.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00268164 on ClinicalTrials.gov Archive Site

Current 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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Ulcerative Colitis

Intervention ^†

Drug: lactobacilus acidophilus & bifidobacterium animalis/lactis

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Denmark

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00268164

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Hvidovre University Hospital

Collaborators ^††

Chr.Hansen A/S, Hoersholm, Denmark

Investigators ^†

Study Chair:

Flemming Bendtsen, MD, DMSci

Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark

Information Provided By

Hvidovre University Hospital

Verification Date

September 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.