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

This study has been completed.
Sponsor:
Collaborators:
University of Southern Denmark
Crohn's and Colitis Foundation
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00374725
First received: September 7, 2006
Last updated: September 8, 2006
Last verified: November 2002
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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
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
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

ClinicalTrials.gov Identifier: NCT00374725     History of Changes
Other Study ID Numbers: VF 20020197
Study First Received: September 7, 2006
Last Updated: September 8, 2006
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:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013