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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00374725

Enrollment

130

Registered

2006-09-11

Start date

2003-02-28

Completion date

2006-05-31

Last updated

2006-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis, Probiotic, Placebo controlled trial, Lactobacillus rhamnosus, Lactobacillus acidophilus

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.

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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number of patients in remission in the two groups at the end of the treatment period	—

Secondary

Measure	Time frame
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	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026