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

Odense University Hospital

Status: Completed

Conditions: Ulcerative Colitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00374725

VF 20020197

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind