Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis
Primary Purpose
Crohn's Disease
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rifabutin, Clarithromycin, and Clofazimine
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Antibiotics
Arm Description
Antibiotics
Outcomes
Primary Outcome Measures
Clinical remission by a decline in Crohns disease activity index to <151
Percent <151
Clinical improvement using inflammatory bowel disease quality of life questionnaire
Improvement in QOL life questionnaire
Endoscopic improvement using Crohn's disease endoscopic activity index
Endoscopic appearance
Secondary Outcome Measures
Full Information
NCT ID
NCT00513552
First Posted
August 6, 2007
Last Updated
August 18, 2020
Sponsor
Medstar Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00513552
Brief Title
Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis
Official Title
Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No patient
Study Start Date
July 2007 (Anticipated)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medstar Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antibiotics
Arm Type
Experimental
Arm Description
Antibiotics
Intervention Type
Drug
Intervention Name(s)
Rifabutin, Clarithromycin, and Clofazimine
Intervention Description
Rifabutin 150 mg by mouth twice daily, Clarithromycin 250 mg by mouth twice a day, and Clofazimine 100 mg by mouth each morning
Primary Outcome Measure Information:
Title
Clinical remission by a decline in Crohns disease activity index to <151
Description
Percent <151
Time Frame
6 Months
Title
Clinical improvement using inflammatory bowel disease quality of life questionnaire
Description
Improvement in QOL life questionnaire
Time Frame
6 Months
Title
Endoscopic improvement using Crohn's disease endoscopic activity index
Description
Endoscopic appearance
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy R Koch, MD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
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Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis
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