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临床试验/NCT03515070
NCT03515070已完成不适用

Microbiome and Genetic Analysis of Family Members With Inflammatory Bowel Disease

Kyunghee University Medical Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Rare genetic variants of inflammatory bowel disease

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Rare genetic variants of inflammatory bowel disease

时间窗: 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.

Genetic risk score of inflammatory bowel disease

时间窗: 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.

Common genetic variants of inflammatory bowel disease

时间窗: 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

时间窗: Three months after the sample collection

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang Kyun Lee

Professor

Kyunghee University Medical Center

研究点 (1)

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