Genetic Studies of Inflammatory Bowel Disease
Genetic Study of Inflammatory Bowel Disease
2 other identifiers
observational
10,000
1 country
5
Brief Summary
This study will examine the existence of genetic regions that are believed to bring about a risk for inflammatory bowel disease (IBD), with its subtypes of Crohn's disease and ulcerative colitis. It will identify the locations of chromosomes responsible for hereditary IBD through linkage analysis, a technique in genetic research in which the occurrence of a disorder in a family is evaluated alongside a known genetic disorder. The project will also do fine mapping of genes and examine possible genes associated with IBD. IBD is a chronic and often disabling disorder of the gastrointestinal tract, affecting about 500,000 Americans. Both Crohn's disease and ulcerative colitis share many characteristics, such as abdominal pain, bloody diarrhea, fever, fatigue, and malnutrition. But the main factors that distinguish these subtypes depend on the location and depth of inflammation. Tests and analyses can generally pinpoint some of the differences between the two, but sometimes there are major overlaps in characteristics, and the diagnosis is known as indeterminate IBD. The exact cause of IBD is not known, but genetic and environmental factors are known to contribute to risk for the disease. The single most important environmental risk factor has been smoking exposure at the time the diagnosis is made. Also, several genetic risk factors are ethnicity, family history, and polymorphisms-abilities to take on different forms-in the NOD2 gene. Patients who have a diagnosis of IBD and their family members 5 years of age and older who have or do not have that diagnosis may be eligible for this study. Participants will be asked to complete a questionnaire on their health, ethnic background, religion, habits, family medical history, and medications. Information will also be sought on the diagnosis, course, complications, and treatment of IBD, as well as risk factors. In addition, there will be collection of blood to be used for DNA preparation, storage of lymphocytes, and information on immunology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2003
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 6, 2003
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2007
CompletedJuly 2, 2017
September 19, 2007
June 19, 2006
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Participants who have a diagnosis of IBD and their family members who have or do not have a diagnosis of IBD will be recruited for this study. Those further selected to be included in the linkage study must have at least two affected family members who are willing to donate blood samples and to fill out medical questionnaires.
You may not qualify if:
- Children who were under the age of 5 years were excluded from the Johns Hopkins University recruitment protocol. There was no age restriction for the University of Chicago or the University of Pittsburgh. Those who were not able to provide consent were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
Boston University Medical Center
Boston, Massachusetts, 02118-2354, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (1)
Lee KS, Medline A, Shockey S. Indeterminate colitis in the spectrum of inflammatory bowel disease. Arch Pathol Lab Med. 1979 Apr;103(4):173-6.
PMID: 581845BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
November 6, 2003
Study Completion
September 19, 2007
Last Updated
July 2, 2017
Record last verified: 2007-09-19