Infectious Agents in Pediatric Crohn's

NCT00237055 | Completed

• 3 other identifiers: R03 DK64544 (completed)NIDDK R03 DK64544R03DK064544
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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), 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:

• 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.

Conditions

Crohn's Disease; Inflammatory Bowel Disease

Keywords

Children; Crohn's disease; Inflammatory bowel disease; Infectious agents; Colonoscopy

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Emory University School of Medicine; Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Benjamin D. Gold, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 11, 2005
• First Posted: October 12, 2005
• Study Start: August 1, 2004
• Study Completion: September 1, 2006
• Last Updated: March 18, 2010

Record last verified: 2010-03

Locations

US (1)