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| Sponsored by: |
Medstar Research Institute |
|---|---|
| Information provided by: | Medstar Research Institute |
| ClinicalTrials.gov Identifier: | NCT00513552 |
Purpose
Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract. The origin of Crohn's disease remains unknown and there is no curative therapy, either medical or surgical, for this gut disorder. It is believed that an infectious agent is important in the development of Crohn's disease. The similarity of Crohn's disease to the animal form of ileitis, termed Johne's disease, supports the possibility that both disorders are caused by exposure to Mycobacterium avium paratuberculosis or MAP.
Multiple investigators have demonstrated good clinical responses of patients with Crohn's disease to treatment with triple antibiotic therapy directed against mycobacterial infection. The hypothesis of this protocol is that triple antibiotic therapy is useful as a medical therapy for patients with Crohn's disease. The aim of this study is to examine the response of patients with Crohn's disease who are not receiving therapy with biological agents to triple antibiotic therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: Rifabutin, Clarithromycin, and Clofazimine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Official Title: | Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | March 2008 |
Clinical remission will be determined by a decline in the Crohns disease activity index to <151; clinical improvement will be examined using the inflammatory bowel disease (IBD) quality of life questionnaire; and endoscopic improvement will be examined using a Crohn's disease endoscopic activity index. All individuals must have had colonoscopy within 3 months of enrollment. An estimated 20 individuals will be enrolled in this protocol. Each patient will be treated for 6 months with a combination of rifabutin, clarithromycin, and clofazimine. At the end of 6 months of treatment for each patient, the Crohns disease activity index will be recalculated, each patient will again complete the IBD quality of life questionnaire, and each patient will undergo repeat colonoscopy.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Timothy R Koch, M.D. | 202-877-7108 | timothy.r.koch@medstar.net |
| United States, District of Columbia | |
| Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Principal Investigator: Timothy R Koch, MD | |
| Principal Investigator: | Timothy R Koch, MD | Washington Hospital Center |
More Information
| Study ID Numbers: | 2006-257, FDA IND 75,897 |
| Study First Received: | August 6, 2007 |
| Last Updated: | August 7, 2007 |
| ClinicalTrials.gov Identifier: | NCT00513552 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Bacterial Infections Anti-Inflammatory Agents Crohn's Disease Rifabutin Gastrointestinal Diseases Paratuberculosis Inflammatory Bowel Diseases Clofazimine Ileal Diseases Anti-Bacterial Agents Clarithromycin Gram-Positive Bacterial Infections Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Ileitis Enteritis Intestinal Diseases Digestive System Diseases Analgesics, Non-Narcotic Crohn Disease Mycobacterium Infections Peripheral Nervous System Agents Antitubercular Agents Gastroenteritis Antirheumatic Agents |
|
Anti-Inflammatory Agents Bacterial Infections Anti-Infective Agents Rifabutin Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Paratuberculosis Inflammatory Bowel Diseases Clofazimine Ileal Diseases Anti-Bacterial Agents Clarithromycin Gram-Positive Bacterial Infections Sensory System Agents |
Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Ileitis Enteritis Enzyme Inhibitors Intestinal Diseases Actinomycetales Infections Pharmacologic Actions Antibiotics, Antitubercular Protein Synthesis Inhibitors Digestive System Diseases Analgesics, Non-Narcotic Crohn Disease Mycobacterium Infections |