Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis

NCT00513552 | Withdrawn Phase 4

• 2 other identifiers: 2006-257FDA IND 75,897
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (3)

• Clinical remission by a decline in Crohns disease activity index to <151

  Percent \<151

  6 Months

• Clinical improvement using inflammatory bowel disease quality of life questionnaire

  Improvement in QOL life questionnaire

  6 Months

• Endoscopic improvement using Crohn's disease endoscopic activity index

  Endoscopic appearance

  6 Months

Study Arms (1)

Antibiotics

EXPERIMENTAL

Antibiotics

Drug: Rifabutin, Clarithromycin, and Clofazimine

Interventions

Rifabutin, Clarithromycin, and Clofazimine DRUG

Rifabutin 150 mg by mouth twice daily, Clarithromycin 250 mg by mouth twice a day, and Clofazimine 100 mg by mouth each morning

Antibiotics

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Rifabutin; Clarithromycin; Clofazimine

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Phenazines; Heterocyclic Compounds, 3-Ring

Study Officials

• Timothy R Koch, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: August 20, 2020

Record last verified: 2020-08