Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
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| ClinicalTrials.gov Identifier: NCT00217022 |
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Recruitment Status :
Terminated
(Study closed early, because of low enrollment.)
First Posted : September 22, 2005
Results First Posted : April 12, 2012
Last Update Posted : November 2, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphocytic Colitis Diarrhea | Other: Placebo Drug: Budesonide | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo Controlled Trial of Budesonide for the Treatment of Active Lymphocytic Colitis |
| Study Start Date : | June 2003 |
| Actual Primary Completion Date : | February 2008 |
| Actual Study Completion Date : | February 2008 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Budesonide
9 mg daily
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Drug: Budesonide
9 mg daily (three tablets)
Other Name: Entocort EC |
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Placebo Comparator: Placebo
three tablets daily
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Other: Placebo
Placebo, 3 tablets daily |
- Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks [ Time Frame: Three out of last four weeks that the subject was on the study ]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.
- Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies [ Time Frame: Baseline (day 1 of study) and at eight weeks (approximately) ]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)).
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217022
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Darrell S. Pardi, M.D. | Mayo Clinic |
Documents provided by Darrell S. Pardi, M.D., Mayo Clinic:
| Responsible Party: | Darrell S. Pardi, M.D., Physician, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00217022 |
| Other Study ID Numbers: |
1132-03 IRUSBUEN0002 ( Other Identifier: AstraZeneca ) UL1RR024150 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 22, 2005 Key Record Dates |
| Results First Posted: | April 12, 2012 |
| Last Update Posted: | November 2, 2021 |
| Last Verified: | October 2021 |
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Lymphocytic Colitis diarrhea budesonide |
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Colitis Colitis, Lymphocytic Diarrhea Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Signs and Symptoms, Digestive Colitis, Microscopic Budesonide |
Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |