Infectious Agents in Pediatric Crohn's

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00237055
First received: October 11, 2005
Last updated: March 17, 2010
Last verified: March 2010
  Purpose

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.

Condition
Crohn's Disease
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Infectious Agents in Pediatric Crohn's Disease

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 500
Study Start Date: August 2004
Estimated Study Completion Date: September 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237055

Locations
United States, Georgia
Emory University School of Medicine; Emory Children's Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Investigators
Principal Investigator: Benjamin D. Gold, M.D. Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00237055     History of Changes
Other Study ID Numbers: R03 DK64544 (completed), NIDDK R03 DK64544
Study First Received: October 11, 2005
Last Updated: March 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Children
Crohn's disease
Inflammatory bowel disease
Infectious agents
Colonoscopy

Additional relevant MeSH terms:
Communicable Diseases
Infection
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014