Status:
COMPLETED
Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
Cepheid
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Crohn's Disease
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief Summary
The inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are chronic conditions affecting approximately 1.4 million Americans. The burden of Clostridium difficile infect...
Detailed Description
This is a two part pilot study, with the initial phase (Aim 1 and Aim 2) being a cross-sectional epidemiological analysis of Clostridium difficile colonization and anti-toxin antibodies in the IBD pop...
Eligibility Criteria
Inclusion
- All subjects must be 18 years of age or older, able to provide written informed consent, and able to comply with the requirements of the study.
- All subjects must speak English. Non-English subjects are not included because of lack of funding for interpreter services and clinical resources could not be used for research purposes.
- For Control Group only: Non-IBD subject seen in CDD during routine visit or on inpatient consult service
- For IBD Group Only: Chart history of IBD (either UC or CD) confirmed by colonoscopy, pathology or gastroenterology clinical judgment
Exclusion
- Any subject planning on moving out of the area in the next year
- Any patient not able to give informed consent
- Any subject unwilling or not able to give stool sample upon enrollment
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01813500
Start Date
October 1 2011
End Date
April 1 2016
Last Update
April 26 2017
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118