Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
Lymphocytic Colitis, Diarrhea
About this trial
This is an interventional treatment trial for Lymphocytic Colitis focused on measuring Lymphocytic Colitis, diarrhea, budesonide
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Budesonide
Placebo
9 mg daily
three tablets daily