Status:
COMPLETED
Infectious Agents in Pediatric Crohn's
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Crohn's Disease
Inflammatory Bowel Disease
Eligibility:
All Genders
6-18 years
Brief Summary
Six sites of the Pediatric Inflammatory Bowel Disease Consortium (plus 2 additional sites) will participate in this study. The participating sites will be that of the Principal Investigator (PI), Emor...
Detailed Description
Inflammatory bowel disease (IBD), which includes CD and ulcerative colitis (UC), is estimated to affect approximately 1 - 2 million Americans. Recent studies strongly suggest that these disorders are ...
Eligibility Criteria
Inclusion
- Each subject must satisfy all of the following inclusion criteria to be considered eligible for entry into this study:
- Patients may be male or female 6 months though 17 11/12 years of age.
- Patients must be undergoing clinically indicated colonoscopy at the discretion of their treating pediatric gastroenterologist.
- Subject's parent or guardian must provide written informed consent, and children who are deemed old enough by the PI at each site must provide informed assent.
Exclusion
- Patients with any of the following characteristics will NOT be eligible for entry into the study:
- Children who are determined to have the diagnosis of indeterminate colitis or ulcerative colitis for the purpose of this R03 - 2-year study will be excluded as cases and from the initial analysis, but will have tissue specimens banked for subsequent evaluation for infectious agents.
- Patient has parent or guardian who refuses to sign the consent form or is not able to give fully informed consent due to mental deficiency or language problems.
- Child who is deemed old enough to give assent and refuses to participate.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00237055
Start Date
August 1 2004
End Date
September 1 2006
Last Update
March 18 2010
Active Locations (1)
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1
Emory University School of Medicine; Emory Children's Center
Atlanta, Georgia, United States, 30322