Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphocytic Colitis, Diarrhea

Intervention / Treatment
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* Other: Placebo
* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Budesonide<br>9 mg daily | Drug: Budesonide<br>* 9 mg daily (three tablets)<br>* Other names: Entocort EC;|
| Placebo Comparator: Placebo<br>three tablets daily | Other: Placebo<br>* Placebo, 3 tablets daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks | 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. | Three out of last four weeks that the subject was on the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies | 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)). | Baseline (day 1 of study) and at eight weeks (approximately) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphocytic Colitis, diarrhea, budesonide