- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374725
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aarhus, Denmark
- Aarhus University Hospital
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Odense, Denmark, 5000 C
- Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Number of patients in remission in the two groups at the end of the treatment period
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Secondary Outcome Measures
Outcome Measure |
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Difference in time to relapse in the two treatment groups
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Number of patients successfully obtaining remission
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Time to remission in the two groups
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Time ro relapse after study treatment is discontinued
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Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VF 20020197
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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