Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.

September 8, 2006 updated by: Odense University Hospital

Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial

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.

Study Overview

Status

Completed

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

Interventional

Enrollment

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
      • Odense, Denmark, 5000 C
        • Dept. of Medical Gastroenterology (afd.S), Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Number of patients in remission in the two groups at the end of the treatment period

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

University of Southern Denmark
Crohn's and Colitis Foundation

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

September 7, 2006

First Submitted That Met QC Criteria

September 8, 2006

First Posted (Estimate)

September 11, 2006

Study Record Updates

Last Update Posted (Estimate)

September 11, 2006

Last Update Submitted That Met QC Criteria

September 8, 2006

Last Verified

November 1, 2002

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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