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

This study has been completed.

First Received: September 7, 2006 Last Updated: September 8, 2006 History of Changes

Sponsor:	Odense University Hospital
Collaborators:	University of Southern Denmark Crohn's and Colitis Foundation
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00374725

Purpose

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.

Condition	Intervention
Ulcerative Colitis	Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial

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 Odense University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	130
Study Start Date:	February 2003
Estimated Study Completion Date:	May 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374725

Locations

Denmark
Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
Odense, Denmark, 5000 C
Aarhus University Hospital
Aarhus, Denmark

Sponsors and Collaborators

Odense University Hospital

University of Southern Denmark

Crohn's and Colitis Foundation

Investigators

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

More Information

No publications provided

Study ID Numbers:	VF 20020197
Study First Received:	September 7, 2006
Last Updated:	September 8, 2006
ClinicalTrials.gov Identifier:	NCT00374725 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by Odense University Hospital:

Ulcerative Colitis
Probiotic
Placebo controlled trial
Lactobacillus rhamnosus
Lactobacillus acidophilus

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 November 30, 2009