NCT03264690已完成不适用
A Prospective Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3
研究概览
简要总结
This study will be conducted to observe the difference in microbiome composition between healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor necrosis factor (anti-TNF) treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Inclusion Criteria For Inflammatory Bowel Disease (IBD) participants:
- •Male or female, age ≥ 19 years at the time of informed consent
- •Confirmed diagnosis of IBD
- •Participants who are naïve to anti-tumour necrosis factor (anti-TNF)
- •Exclusion Criteria for IBD participants:
- •Contraindication to anti-TNF including active tuberculosis (TB), sepsis, or other severe opportunistic infection, etc.
- •Inclusion/ Exclusion Criteria:
- •Inclusion Criteria for non-IBD participants:
- •Participants who have not been diagnosed with IBD
- •Participants who don't have any other intestinal disease except IBD
- •Participants who are naïve to anti-TNF
- •Exclusion Criteria for non-IBD participants:
- •Participants who have been on medication to treat underlying disease for the previous 3 months
结局指标
主要结局
Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3
时间窗: Month 3
Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed.
次要结局
- Change from baseline in calprotectin at Month 3(Baseline; Month 3)
- Disease activity will be assessed by Crohn's Disease Activity Index (CDAI) or Mayo score for ulcerative colitis (UC)(Up to 3 months)
- Correlation in the composition of the microbiome at baseline and disease activity will be assessed as measured by CDAI or Mayo score at Month 3(Baseline; Month 3)
- The difference in the composition of the microbiome at baseline between IBD participants and non-IBD participants(Baseline)
- Number of participants with abnormal, clinically significant vital signs(Up to 3 months)
研究者
研究点 (3)
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