Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00513552
Recruitment Status : Unknown
Verified August 2007 by Medstar Health Research Institute.
Recruitment status was:  Recruiting
First Posted : August 8, 2007
Last Update Posted : August 8, 2007
Sponsor:
Information provided by:
Medstar Health Research Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Crohn's Disease Drug: Rifabutin, Clarithromycin, and Clofazimine Phase 4

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis
Study Start Date : January 2007
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Rifabutin, Clarithromycin, and Clofazimine
    Rifabutin 150 mg by mouth twice daily, Clarithromycin 250 mg by mouth twice a day, and Clofazimine 100 mg by mouth each morning

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT00513552


Contacts
Layout table for location contacts
Contact: Timothy R Koch, M.D. 202-877-7108 timothy.r.koch@medstar.net

Locations
Layout table for location information
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 Health Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Timothy R Koch, MD Washington Hospital Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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.

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00513552    
Other Study ID Numbers: 2006-257
FDA IND 75,897
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: August 8, 2007
Last Verified: August 2007
Additional relevant MeSH terms:
Layout table for MeSH terms
Mycobacterium avium-intracellulare Infection
Paratuberculosis
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Anti-Bacterial Agents
 Clarithromycin
Rifabutin
Clofazimine
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Inflammatory Agents
Leprostatic Agents