Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT00374725
- Lead Sponsor
- Odense University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- Patients with known ulcerative colitis
- At least one prior flare of the disease
- Clinically and endoscopically active disease
- Age: 18 and above
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of patients in remission in the two groups at the end of the treatment period
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
🇩🇰Odense, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark