Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | January 2007 |
| End Date: | March 2008 |
| Contact: | Timothy R Koch, M.D. |
| Email: | timothy.r.koch@medstar.net |
| Phone: | 202-877-7108 |
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.
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.
<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.
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.
We found this trial at
1
site
110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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