Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis - Full Text View

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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Antibiotics Crohn's Disease

Drug Information available for: Rifabutin Clarithromycin Clofazimine

U.S. FDA Resources

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:

Clinical remission by a decline in Crohns disease activity index to <151 [ Time Frame: 6 Months ]
Clinical improvement using inflammatory bowel disease quality of life questionnaire [ Time Frame: 6 Months ]
Endoscopic improvement using Crohn's disease endoscopic activity index [ Time Frame: 6 Months ]

Estimated Enrollment:	20
Study Start Date:	January 2007
Estimated Study Completion Date:	March 2008

Intervention Details:

Rifabutin 150 mg by mouth twice daily, Clarithromycin 250 mg by mouth twice a day, and Clofazimine 100 mg by mouth each morning

Detailed Description:

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

Criteria

Inclusion Criteria:

This study will only include patients capable of providing informed consent, ages 18 and older.
Patients must have a documented diagnosis of Crohn's disease and have had a colonoscopy with photographs within 3 months prior to randomization.
All patients must have a CDAI of 220 or greater at enrollment.
All females must be post-menopausal, surgically sterilized, or either abstain from sexual intercourse or use a non-hormonal method of birth control other than or in addition to oral contraceptive during the study and for 6 weeks after the end of the study.

Exclusion Criteria:

Any patient with ulcerative colitis
All women of child-bearing age must have a negative urine pregnancy test within 1 week prior to the initial clinic visit.
Patients receiving a biological therapy for Crohn's disease including remicade
Patients with a known allergy to any of the three antibiotics used in this protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513552

Contacts

Contact: Timothy R Koch, M.D.

202-877-7108

timothy.r.koch@medstar.net

Locations

United States, District of Columbia
Washington Hospital Center	Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Timothy R Koch, MD

Sponsors and Collaborators

Medstar Research Institute

Investigators

Principal Investigator:

Timothy R Koch, MD

Washington Hospital Center

More Information

Publications:

Karp SM, Koch TR, Pang G. Is there a MAP (Mycobacterium Avium Subspecies Paratuberculosis) for treating Crohn's disease? Practical Gastroenterology 31(4):40-50, 2007.

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on July 06, 2009