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

This study has been completed.

Sponsors and Collaborators: Odense University Hospital
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)

Genetics Home Reference related topics:   Crohn disease   

MedlinePlus related topics:   Ulcerative Colitis   

ChemIDplus related topics:   Lactobacillus acidophilus   

U.S. FDA Resources

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

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

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

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

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on August 29, 2008




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