Clinical trial NCT00217022: Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
Official title: A Randomized, Double-Blind, Placebo Controlled Trial of Budesonide for the Treatment of Active Lymphocytic Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Lymphocytic Colitis
Diarrhea
Keywords: Lymphocytic Colitis
diarrhea
budesonide
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: National Center for Research Resources (NCRR)
First posted: 2005-09-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Diarrhea, defined as greater than 4 bowel movements per day and greater than "mild"; currently on no treatment or active despite treatment.
* Lymphocytic colitis confirmed histologically within one year of enrollment

Exclusion Criteria:

* Previous unsuccessful treatment with corticosteroids or immunosuppressive drugs
* History of severe corticosteroid side effects
* Corticosteroid, ticlopidine, or flutamide use within the previous 4 weeks
* Antibiotic, mesalamine or bismuth subsalicylate use within two weeks
* Current use of anticholinergics, cholestyramine, narcotics, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or grapefruit juice
* Known active medical conditions, including cancer, infection, uncontrolled hypertension or diabetes, osteoporosis, peptic ulcer disease, glaucoma, cataracts, liver cirrhosis or history of tuberculosis
* Other diarrheal conditions (sprue, infection, hyperthyroidism, lactose intolerance)
* Pregnant or nursing females
* Patients without a telephone or unable to communicate in English over the telephone, or unable or unwilling to give consent
* Known hypersensitivity to or intolerance of budesonide.

Primary outcomes:
measure: Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks
timeFrame: Three out of last four weeks that the subject was on the study
Secondary outcomes:
measure: Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies
timeFrame: Baseline (day 1 of study) and at eight weeks (approximately)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Darrell S. Pardi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: