An observational study in Inflammatory Bowel Diseases, sponsored by Kyunghee University Medical Center. Completed at 1 site in South Korea. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Kyunghee University Medical Center · Observational
Inflammatory bowel disease(IBD) is a chronic inflammatory condition for gastrointestinal tract.
Regarding its pathogenesis, there has been numerous studies to reveal the complex association between genetic and environmental factors.
In Korea, the incidence of IBD is growing rapidly but genetic studies solely including patients with Korean descent were not sufficient enough.
Therefore, the investigators planned to conduct genetic and fecal microbial analysis for the 60 individuals from 30 Korean IBD families to find out the pathogenesis of IBD.
Under the hypothesis that more risk variants will be observed among the familial IBD patient than in IBD patients without any other affected family members, the investigators designed genetic and fecal microbiome analysis for 60 patients form 30 families.
After extracting the DNA from blood samples, whole genome sequencing will be performed and data will be comprared with the previously reported variances. Novel variances or incidence of specific variances will be measured.
Genome-wide single nucleotide polymorphism array using Immunochip will be performed to search common genetic variants and to calculate genetic risk score of IBD.
In this study, fecal microbiome is a surrogate marker for the enviromental aspect of pathogenesis of IBD. The investigators assumed that family members are sharing similar mode of lifestyle therefore we're presumed that their fecal microbial composition is alike.
Comparing genetic and microbial datas altogether with the data from unaffected family member(Healthy internal control), investigators expecting to explain the genetic and enviromental aspect of IBD pathogenesis.
1,487 studies on the registry are indexed under Inflammatory Bowel Diseases; 434 are open to participants now.
This study's enrollment of 25 is below the median of 146 across 659 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Kyunghee University Medical Center is the lead sponsor of 63 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The investigators are planned to study family members with IBD(Crohn's disease or ulcerative colitis).
They are all Koreal descent and study candidates are two patients from each 30 families. As a healthy internal control, another family member without IBD history will be also enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Rare genetic variants of inflammatory bowel disease
Results from whole genome sequencing of blood samples of study participants. Planned to compare with the previously reported variances.
Time frame: Three months after the sample collection
Common genetic variants of inflammatory bowel disease
Results from genome-wide single nucleotide polymorphism array of blood samples of study participants. Planned to compare with the previously reported variances.
Time frame: Three months after the sample collection
Genetic risk score of inflammatory bowel disease
Results from genome-wide single nucleotide polymorphism array of blood samples of study participants. Planned to compare with the previously reported variances.
Time frame: Three months after the sample collection
Fecal microbiome composition of each study subjects
Microbial diversity measured from 16S RNA sequencing datas of fecal microbiomes.
Time frame: Three months after the sample collection
Plan to share: Undecided — After publishing the results, any data sharing request from other researchers will be positively considered. But extent of sharing is not decided yet.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Kyunghee University Medical Center