Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
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ClinicalTrials.gov Identifier: NCT00833170 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 30, 2009
Last Update Posted
: January 26, 2018
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Condition or disease |
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Inflammatory Bowel Disease |
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.
Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry |
Actual Study Start Date : | January 28, 2002 |
Estimated Primary Completion Date : | August 2019 |
Estimated Study Completion Date : | August 2019 |
- Clinical activity following biologic and immunomodulatory therapy [ Time Frame: 10 years ]Clinical Outcomes
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 1 Month to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Definite diagnosis of ulcerative colitis, Crohn's disease, indeterminate colitis
- Age up to 16 years and zero days at time of diagnosis
- Informed consent/assent from parent/guardian and patient
- Ability to be available for regular follow-up visits
Exclusion Criteria:
- Diagnosis of IBD greater than 1 month prior to presentation to participating center
- Age greater than 16 years and zero days
- Inability to be available for regular follow-up visits

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833170

Principal Investigator: | Jeffrey S. Hyams, M.D. | Connecticut Children's Medical Center |
Responsible Party: | Jeffrey Hyams, MD, Study Principal Investigator, Connecticut Children's Medical Center |
ClinicalTrials.gov Identifier: | NCT00833170 History of Changes |
Other Study ID Numbers: |
PIBDCRG1 |
First Posted: | January 30, 2009 Key Record Dates |
Last Update Posted: | January 26, 2018 |
Last Verified: | January 2018 |
Keywords provided by Jeffrey Hyams, MD, Connecticut Children's Medical Center:
pediatric inflammatory bowel disease multiple site study |
Additional relevant MeSH terms:
Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |