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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Withdrawn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
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 6, 2007
    Last Updated
    August 18, 2020
    Sponsor
    Medstar Health Research Institute
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    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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