Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00217022
• Other study ID #: 1132-03
• Secondary ID: IRUSBUEN0002UL1R
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 2003
• Est. completion date: February 2008

Study information

• Verified date: October 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Diarrhea
• Lymphocytic Colitis

Intervention

Other:
• Placebo
Placebo, 3 tablets daily

Drug:
• Budesonide
9 mg daily (three tablets)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	AstraZeneca, National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)

External Links

•   Mayo Clinic Clinical Trials