Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. - Tabular View

Tracking Information

First Received Date ^ICMJE

September 7, 2006

Last Updated Date

September 8, 2006

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Number of patients in remission in the two groups at the end of the treatment period

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00374725 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Difference in time to relapse in the two treatment groups
Number of patients successfully obtaining remission
Time to remission in the two groups
Time ro relapse after study treatment is discontinued

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.

Official Title ^ICMJE

Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial

Brief Summary

In this trial we test the hypothesis that a probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus is an effective therapy for patients with ulcerative colitis.

Detailed Description

In the recent years there has been an increasing interest in the relationship between the gastrointestinal flora and gut function. Several studies have shown promising results for the use of probiotics in patient with inflammatory bowel disease.

In this trial approximately 100 patients with ulcerative colitis will receive treatment with probiotic or placebo for 8 to 10 months as adjuvant therapy.

The trial is double-blind, randomised and controlled.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Ulcerative Colitis

Intervention ^ICMJE

Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus)

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 ^ICMJE

Completed

Enrollment ^ICMJE

130

Completion Date

May 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with known ulcerative colitis
At least one prior flare of the disease
Clinically and endoscopically active disease
Age: 18 and above

Exclusion Criteria:

Changes in azathioprine dosage within the last three months
Patients with toxic megacolon, peritoneal reaction or severe colonic bleeding
Known immunodeficiencies
On-going infectious disease
On-going treatment with NSAID or cholestyramine
Pregnant og lactating women

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00374725

Responsible Party

Study ID Numbers ^ICMJE

VF 20020197

Study Sponsor ^ICMJE

Odense University Hospital

Collaborators ^ICMJE

University of Southern Denmark
Crohn's and Colitis Foundation

Investigators ^ICMJE

Principal Investigator:	Lone G Klinge, MD	Odense University Hospital
Principal Investigator:	Jens Kjeldsen, MD, PhD	Odense University Hospital
Study Chair:	Karsten Lauritsen, MD, Dr.med.	Odense University Hospital
Principal Investigator:	Lisbeth Ambrosius, MD,Dr.med.	Aarhus University Hospital

Information Provided By

Odense University Hospital

Verification Date

November 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP