Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.
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.
Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial|
- 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
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||May 2006|
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.
|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|