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Recruitment Status : Withdrawn (No patient)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
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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|