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

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00374725

Collaborator

University of Southern Denmark (Other), Crohn's and Colitis Foundation (Other)

130

Enrollment

Locations

38.9

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus)	N/A

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 Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2003

Study Completion Date :

May 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark
2	Dept. of Medical Gastroenterology (afd.S), Odense University Hospital	Odense		Denmark	5000 C

Sponsors and Collaborators

Odense University Hospital
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