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临床试验/NCT03841045
NCT03841045Unknown不适用

Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases

Soroka University Medical Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年9月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
change of bilirubin metabolism in fecal samples

研究概览

简要总结

Inflammatory Bowel Diseases (IBDs) are a set of recurrent inflammatory conditions that include the colon and small intestine. The two principal conditions include Crohn's disease (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay of gut microbial imbalances and host. In this study stool cultures, saliva and skin samples will be taken from all participants.

详细描述

Recent studies have shown that certain CD patients harbor microbial communities that are distinct from those of healthy individuals. These studies suggest a central role of the gut microbial population in CD. The high complexity of the gut microbiome, which is the most densely populated bacterial niche, makes the identification of these bacteria a significant challenge. The bacterial population is comprised from 1013 - 1014 individuals, all belonging roughly to a thousand different species, mostly anaerobic, and most of them (roughly 70% - 80%) are uncultivable.

The goals of this project are to examine a potential link between bilirubin metabolism and IBD, by comparing fecal extracts from healthy humans and IBD patients, and to investigate the underlying mechanism explaining these differences.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • healthy Volunteers

排除标准

  • 未提供

结局指标

主要结局

change of bilirubin metabolism in fecal samples

时间窗: an average of 1 year after recruitment

liquid chromatography / mass spectrometric (LCMS) analysis is applied to bilirubin metabolism comparison between IBD patients and healthy humans in fecal extracts

microbial diversity of fecal matter

时间窗: an average of 1 year after recruitment

16S rRNA sequencing, is used to compare the microbial diversity between healthy individuals and IBD patients

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

ARIK SEGAL MD

principal investigator

Soroka University Medical Center

研究点 (1)

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