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
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Completion Date :||May 2006|
- Number of patients in remission in the two groups at the end of the treatment period
- 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
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|
|Dept. of Medical Gastroenterology (afd.S), Odense University Hospital|
|Odense, Denmark, 5000 C|
|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|