Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis
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ClinicalTrials.gov Identifier: NCT00513552 |
Recruitment Status :
Withdrawn
(No patient)
First Posted : August 8, 2007
Last Update Posted : August 20, 2020
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Antibiotics
Antibiotics
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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 |
- Clinical remission by a decline in Crohns disease activity index to <151 [ Time Frame: 6 Months ]Percent <151
- Clinical improvement using inflammatory bowel disease quality of life questionnaire [ Time Frame: 6 Months ]Improvement in QOL life questionnaire
- Endoscopic improvement using Crohn's disease endoscopic activity index [ Time Frame: 6 Months ]Endoscopic appearance

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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 |
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.

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
Principal Investigator: | Timothy R Koch, MD | Medstar Health Research Institute |
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 |
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 |