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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Recruitment Status : Withdrawn (No patient)
First Posted : August 8, 2007
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Timothy Koch, Medstar Health Research Institute

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
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
Estimated Study Start Date : July 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Antibiotics
Antibiotics
 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
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Primary Outcome Measures :
  1. Clinical remission by a decline in Crohns disease activity index to <151 [ Time Frame: 6 Months ]
    Percent <151

  2. Clinical improvement using inflammatory bowel disease quality of life questionnaire [ Time Frame: 6 Months ]
    Improvement in QOL life questionnaire

  3. Endoscopic improvement using Crohn's disease endoscopic activity index [ Time Frame: 6 Months ]
    Endoscopic appearance


Eligibility Criteria
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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
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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


Sponsors and Collaborators
Medstar Health Research Institute
Investigators
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Principal Investigator: Timothy R Koch, MD Medstar Health Research Institute
More Information
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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.

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Responsible Party: Timothy Koch, Physician, Medstar Health Research Institute
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 20, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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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
Bacterial Infections and Mycoses
Infections
Mycobacterium Infections, Nontuberculous
 Clarithromycin
Rifabutin
Clofazimine
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Inflammatory Agents
Leprostatic Agents