Microbiome and Genetic Analysis of Familial IBD

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyung Hee University Medical Center

Seoul, 180-702, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

60 individuals from 30 families of Crohn's disease or ulcerative colitis.
Unaffected 30 individuals from each family as healthy internal control.

Exclusion criteria

Person with history of using antibiotics or probiotics within previous 4 weeks.

Treatment and study plan

Primary outcomes

Rare genetic variants of inflammatory bowel disease

Time frame: Three months after the sample collection

Results from whole genome sequencing of blood samples of study participants. Planned to compare with the previously reported variances.
Common genetic variants of inflammatory bowel disease

Time frame: Three months after the sample collection

Results from genome-wide single nucleotide polymorphism array of blood samples of study participants.

Planned to compare with the previously reported variances.
Genetic risk score of inflammatory bowel disease

Time frame: Three months after the sample collection

Results from genome-wide single nucleotide polymorphism array of blood samples of study participants.

Planned to compare with the previously reported variances.
Fecal microbiome composition of each study subjects

Time frame: Three months after the sample collection

Microbial diversity measured from 16S RNA sequencing datas of fecal microbiomes.

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Official study title

Microbiome and Genetic Analysis of Family Members With Inflammatory Bowel Disease

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: May 3, 2018
Registry last updated: Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed