Back to resultsTreatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Administration of probiotic (L. rhamnosus and L. acidophilus)
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Probiotic, Placebo controlled trial, Lactobacillus rhamnosus, Lactobacillus acidophilus
Eligibility Criteria
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
Sites / Locations
- Aarhus University Hospital
- Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
Outcomes
Primary Outcome Measures
Number of patients in remission in the two groups at the end of the treatment period
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00374725
First Posted
September 7, 2006
Last Updated
September 8, 2006
Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark, Crohn's and Colitis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00374725
Brief Title
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.
Official Title
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2002
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark, Crohn's and Colitis Foundation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, Probiotic, Placebo controlled trial, Lactobacillus rhamnosus, Lactobacillus acidophilus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
130 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Administration of probiotic (L. rhamnosus and L. acidophilus)
Primary Outcome Measure Information:
Title
Number of patients in remission in the two groups at the end of the treatment period
Secondary Outcome Measure Information:
Title
Difference in time to relapse in the two treatment groups
Title
Number of patients successfully obtaining remission
Title
Time to remission in the two groups
Title
Time ro relapse after study treatment is discontinued
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lone G Klinge, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Kjeldsen, MD, PhD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karsten Lauritsen, MD, Dr.med.
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lisbeth Ambrosius, MD,Dr.med.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
City
Odense
ZIP/Postal Code
5000 C
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.
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