Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

Mayo Clinic

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Diarrhea

Lymphocytic Colitis

Treatments

Drug: Budesonide

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00217022

UL1RR024150 (U.S. NIH Grant/Contract)

1132-03

IRUSBUEN0002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.