Clinical Trial: Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo Controlled Trial of Budesonide for the Treatment of Active Lymphocytic Colitis

Brief Summary: Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of diarrhea in lymphocytic colitis.

Detailed Summary:

Microscopic colitis is an increasingly diagnosed cause of chronic diarrhea, with two main subtypes: collagenous and lymphocytic colitis. Uncontrolled reports have suggested that various drugs can be beneficial in treating microscopic colitis, but few treatments have been evaluated in randomized controlled trials. Thus, treatment is guided mostly by anecdotal reports, case series, and physicians' experience. In our uncontrolled experience, corticosteroids are one of the most effective therapies for microscopic colitis, but are not typically used as a first line therapy because of toxicity. Budesonide has been reported to be of clinical benefit in small, uncontrolled series of patients with microscopic colitis, and recent controlled trials showed that it is superior to placebo in collagenous colitis. We propose a study of budesonide in patients with the lymphocytic type of microscopic colitis.

Patients will have stool specimen and blood drawn at the start of the study. Patient will take either Budesonide or placebo for 8 weeks. At the end of treatment, patient will have stool collection and sigmoidoscopy.


Sponsor: Mayo Clinic

Current Primary Outcome: Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks [ Time Frame: Three out of last four weeks that the subject was on the study ]

Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of "satisfactory control" of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks.


Original Primary Outcome: Satisfactory control of diarrhea during at least three of the last four weeks.

Current Secondary Outcome: Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies [ Time Frame: Baseline (day 1 of study) and at eight weeks (approximately) ]

The histopathology scoring system included epithelial damage, lamina propria cellularity and intraepithelial lymphocytosis, each scored on a four point scale ("normal" (0), "mildly increased" (1), "moderately increased" (2), "severely increased" (3)).


Original Secondary Outcome:

  • Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies
  • Side effects and time(in days) to recurrence of diarrhea after discontinuation of study drug.


Information By: Mayo Clinic

Dates:
Date Received: September 14, 2005
Date Started: June 2003
Date Completion:
Last Updated: March 16, 2012
Last Verified: March 2012