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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00374725
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : September 11, 2006
Information provided by:

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial
Study Start Date : February 2003
Estimated Study Completion Date : May 2006

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Number of patients in remission in the two groups at the end of the treatment period

Secondary Outcome Measures :
  1. Difference in time to relapse in the two treatment groups
  2. Number of patients successfully obtaining remission
  3. Time to remission in the two groups
  4. Time ro relapse after study treatment is discontinued

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374725

Aarhus University Hospital
Aarhus, Denmark
Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
Odense, Denmark, 5000 C
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Crohn's and Colitis Foundation
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

ClinicalTrials.gov Identifier: NCT00374725     History of Changes
Other Study ID Numbers: VF 20020197
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: November 2002

Keywords provided by Odense University Hospital:
Ulcerative Colitis
Placebo controlled trial
Lactobacillus rhamnosus
Lactobacillus acidophilus

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases