Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

Inflammatory Bowel Disease Clinical Trial

Official title:

Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833170
• Other study ID #: PIBDCRG1
• Status: Completed
• Start date: January 28, 2002
• Est. completion date: June 1, 2014

Study information

• Verified date: February 2019
• Source: Connecticut Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry is to study the contemporary natural history of children <16 years of age newly diagnosed with inflammatory bowel disease. The project follows these children quarterly from diagnosis examining clinical, laboratory, and humanistic outcomes. Genetic and serologic monitoring is performed on the study population.

Description:

Observations of children with IBD often suggest a more severe course than that found in adults. Explanations for this are unclear, especially since children are less likely to engage in some behaviors (e.g., smoking) that may have a deleterious effect on disease course as noted in adults. In many ways children are a better "experimental model" of IBD because they don't have as many confounding medical factors as adults. Both Crohn's disease and ulcerative colitis are believed to result from a complex interaction of genetic and environmental factors (1). Recently, the gene CARD15/NOD2 on chromosome 16 has been identified in approximately 25% of Caucasian patients with Crohn's disease and is felt to be a significant predisposing factor to the development of fibrostenosing disease (2). Additionally, seropositivity for perinuclear antinuclear cytoplasmic factor (pANCA) has been demonstrated much more frequently in patients with ulcerative colitis than in those with Crohn's disease, while anti-Saccharomyces antibody (ASCA) is more common in the latter population (3). The importance of these serological abnormalities is not clear, though some data suggest an influence on the development of complications.

Our hypothesis is that phenotypic, genotypic and serologic characteristics may provide prognostic information on response to therapy and course in children with IBD. This type of prognostic information is particularly important as newer therapies are developed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: June 1, 2014
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

Inclusion Criteria:

1. Definite diagnosis of ulcerative colitis, Crohn's disease, indeterminate colitis

2. Age up to 16 years and zero days at time of diagnosis

3. Informed consent/assent from parent/guardian and patient

4. Ability to be available for regular follow-up visits

Exclusion Criteria:

1. Diagnosis of IBD greater than 1 month prior to presentation to participating center

2. Age greater than 16 years and zero days

3. Inability to be available for regular follow-up visits

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
Canada	IWK Health Centre,	Halifax	Nova Scotia
Canada	CHU Sainte-Justine Hospital	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Hospital for Sick Children	Toronto	Ontario
United States	Emory University	Atlanta	Georgia
United States	The John's Hopkins Medical Institute	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Children's Hospital	Boston	Massachusetts
United States	Children's Hospital At Montefiore	Bronx	New York
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Dayton Children's Medical Center	Dayton	Ohio
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	James Whitcomb Riley Hospital for Children	Indianapolis	Indiana
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Steven & Alexandra Cohen Children's Medical Center	New Hyde Park	New York
United States	The Children's Hospital	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mayo Clinic	Rochester	Minnesota
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Childrens Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center	Centocor, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical activity following biologic and immunomodulatory therapy	Clinical Outcomes	10 years