A Phase 4 interventional study of Rifabutin, Clarithromycin, and Clofazimine in Crohn's Disease, sponsored by Medstar Health Research Institute. Withdrawn. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-08-20.
Sponsored by Medstar Health Research Institute · Phase 4, Interventional, and Treatment
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.
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.
72 studies on the registry are indexed under Mycobacterium avium-intracellulare Infection; 8 are open to participants now.
Browse Mycobacterium avium-intracellulare Infection studies →Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
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Exclusion Criteria:
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
Clinical remission by a decline in Crohns disease activity index to <151
Percent \<151
Time frame: 6 Months
Clinical improvement using inflammatory bowel disease quality of life questionnaire
Improvement in QOL life questionnaire
Time frame: 6 Months
Endoscopic improvement using Crohn's disease endoscopic activity index
Endoscopic appearance
Time frame: 6 Months
No study locations are listed for this record.
This study is withdrawn, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Mycobacterium avium-intracellulare Infection→
Medstar Health Research Institute