Inflammatory Bowel Disease Clinical Trial
Official title:
Genetic Study of Inflammatory Bowel Disease
Verified date | September 19, 2007 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10000 |
Est. completion date | September 19, 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
- INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland |
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
United States | Boston University Medical Center | Boston | Massachusetts |
United States | University of Chicago | Chicago | Illinois |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Human Genome Research Institute (NHGRI) |
United States,
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. — View Citation
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