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

NCT ID: NCT00374725

Last Updated: 2006-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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Ulcerative Colitis

Keywords

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Ulcerative Colitis Probiotic Placebo controlled trial Lactobacillus rhamnosus Lactobacillus acidophilus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Administration of probiotic (L. rhamnosus and L. acidophilus)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Crohn's and Colitis Foundation

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Lone G Klinge, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Jens Kjeldsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Karsten Lauritsen, MD, Dr.med.

Role: STUDY_CHAIR

Odense University Hospital

Lisbeth Ambrosius, MD,Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Dept. of Medical Gastroenterology (afd.S), Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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VF 20020197

Identifier Type: -

Identifier Source: org_study_id