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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374725
• Other study ID #: VF 20020197
• Status: Completed
• Phase: N/A
• First received: September 7, 2006
• Last updated: September 8, 2006
• Start date: February 2003
• Est. completion date: May 2006

Study information

• Verified date: November 2002
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Behavioral:
• Administration of probiotic (L. rhamnosus and L. acidophilus)

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Dept. of Medical Gastroenterology (afd.S), Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Crohn's and Colitis Foundation, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients in remission in the two groups at the end of the treatment period
Secondary	Difference in time to relapse in the two treatment groups
Secondary	Number of patients successfully obtaining remission
Secondary	Time to remission in the two groups
Secondary	Time ro relapse after study treatment is discontinued