NCT00374725CompletedNot Applicable
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial
Odense University Hospital3 sites in 1 country130 target enrollmentStarted: February 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Odense University Hospital
- Enrollment
- 130
- Locations
- 3
- Primary Endpoint
- Number of patients in remission in the two groups at the end of the treatment period
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of patients in remission in the two groups at the end of the treatment period
Secondary Outcomes
- 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
Investigators
Study Sites (3)
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