Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Medstar Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00513552
First received: August 6, 2007
Last updated: August 7, 2007
Last verified: August 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis

Resource links provided by NLM:


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:
    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
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
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, see Learn About Clinical Studies.

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.

ClinicalTrials.gov Identifier: NCT00513552     History of Changes
Other Study ID Numbers: 2006-257, FDA IND 75,897
Study First Received: August 6, 2007
Last Updated: August 7, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Paratuberculosis
Actinomycetales Infections
Bacterial Infections
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Gram-Positive Bacterial Infections
Inflammatory Bowel Diseases
Intestinal Diseases
Mycobacterium Infections, Nontuberculous
Clarithromycin
Clofazimine
Rifabutin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014