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Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.
This study has been completed.
Study NCT00374725   Information provided by Odense University Hospital
First Received: September 7, 2006   Last Updated: September 8, 2006   History of Changes

September 7, 2006
September 8, 2006
February 2003
 
Number of patients in remission in the two groups at the end of the treatment period
Same as current
Complete list of historical versions of study NCT00374725 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial

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.

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.

 
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Ulcerative Colitis
Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
130
May 2006
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00374725
 
VF 20020197
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
Odense University Hospital
November 2002

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