Crohn's Disease Clinical Trial
Official title:
Infectious Agents in Pediatric Crohn's Disease
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), Emory University School of Medicine, Atlanta, GA (Benjamin D. Gold, MD);
Texas Children's Hospital / Baylor College of Medicine (George Ferry, MD and Tony Olive,
MD); Children's Hospital of Philadelphia, Philadelphia, PA (Bob Baldassano, MD); University
of Chicago Children's Hospital, Chicago, IL (Barbara Kirschner, MD); University of
California, San Francisco (Mel Heyman, MD); Mass General Hospital / Harvard University
(Harland Winter, MD); V.A. Stanford University School of Medicine, Stanford, CA (David
Relman, MD); Children's Center For Digestive Healthcare, Atlanta, GA (Stanley Cohen, MD);
and Centers for Disease Control and Prevention, Atlanta, GA (Drs. Jeannette Guarner, Siobhan
O'Connor and Thomas Shinnick)
The duration of study is 2 yrs.
Objectives:
1. Improve the methods to collect biopsies from the colon and ileum, tissue storage
techniques and best methods to detect specific infections in children with Crohn's
disease;
2. Determine if there are specific infectious agents that are more common in children with
Crohn's disease, and;
3. Determine if there are types of children with Crohn's disease (e.g., children living in
Boston, African American children) who may be more at risk for getting the infections.
The study design involves children ages 6 months through 17 11/12 years of age who are
undergoing a clinically-indicated colonoscopy. Subjects will be grouped into cases and
controls.
- Any child ages 6 mos through 17 11/12 years of age, undergoing a clinically-indicated
colonoscopy as determined by the treating physician, is eligible for enrollment. About
500 patients will be enrolled in this study.
- Cases will consist of those children within the defined age group, who are undergoing
diagnostic colonoscopy and have the definitive diagnosis of Crohn's disease.
- Children who have the diagnosis of indeterminate colitis or ulcerative colitis for the
purpose of this R03, will be excluded as cases and from initial analysis, but will have
tissue specimens banked for subsequent evaluation for infectious agents.
- Controls will consists of children within the defined age group, undergoing clinically
indicated colonoscopy and who are not diagnosed with Crohn's disease, ulcerative
colitis or indeterminate colitis (e.g., juvenile polyps, irritable bowel syndrome or
functional bowel disease).
- Stool specimen (5ml/1 tsp) will be collected to test for different types of bacteria
- A questionnaire will be administered to each research volunteer.
- Each subject's medical information (i.e. diagnosis, disease stage, and laboratory
results) will be stored electronically in a separate access-based database. A unique
identifier will be assigned to each patient entered into the study and will also be
used for blinding of the specimens analyzed by the pathologist and by molecular assays
for infectious agents.
- Colonoscopy will be performed by the treating pediatric gastroenterologist and biopsies
obtained in the usual standard of care.
- Clinical biopsies from the rectum, left, right, transverse colon and cecum will be
placed in formalin containing vials as per standard of care for the clinical
pathologist and diagnostic evaluation.
Status | Completed |
Enrollment | 500 |
Est. completion date | September 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 18 Years |
Eligibility |
Inclusion Criteria: Each subject must satisfy all of the following inclusion criteria to be considered eligible for entry into this study: 1. Patients may be male or female 6 months though 17 11/12 years of age. 2. Patients must be undergoing clinically indicated colonoscopy at the discretion of their treating pediatric gastroenterologist. 3. 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 Criteria: Patients with any of the following characteristics will NOT be eligible for entry into the study: 1. 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. 2. 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. 3. Child who is deemed old enough to give assent and refuses to participate. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Emory University School of Medicine; Emory Children's Center | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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