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

NCT ID: NCT00513552

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2007-07-31

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.

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antibiotics

Antibiotics

Group Type: EXPERIMENTAL

Rifabutin, Clarithromycin, and Clofazimine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Timothy Koch

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy R Koch, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

References

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.

Reference Type: BACKGROUND

Other Identifiers

FDA IND 75,897

Identifier Type: -

Identifier Source: secondary_id

2006-257

Identifier Type: -

Identifier Source: org_study_id