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临床试验/NCT04079335
NCT04079335Unknown不适用

A Prospective Longitudinal Study of Fecal Microbiome and Calprotectin to Predict Relapse in Patients With Inflammatory Bowel Disease

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Clinical relapse for UC patients

研究概览

简要总结

Inflammatory bowel disease (IBD) is a chronic idiopathic inflammatory condition of the intestine, which results in diarrhea, rectal bleeding, urgency, weight loss and abdominal pain. The natural course of IBD is characterized by activity outbreaks and periods of remission. In most cases, relapses in Crohn's disease (CD) and in ulcerative colitis (UC) are unpredictable and despite effective medical treatment, a degree of subclinical inflammation may persist in the bowel wall, contributing to a significant risk of relapse.

In IBD, altered fecal microbiota signatures have been consistently reported which included a reduction in biodiversity with lower proportions of Firmicutes and increases in Proteobacteria and Bacteroidetes phylum members.

It is however unclear whether changes in microbial profile including diversity and composition can predict disease relapse in IBD. We hypothesize that fecal microbial signatures in conjunction with fecal calprotectin may play a role in predicting relapse in IBD patients.

详细描述

Inflammatory bowel disease (IBD) is a chronic idiopathic inflammatory condition of the intestine, which results in diarrhea, rectal bleeding, urgency, weight loss and abdominal pain. The natural course of IBD is characterized by activity outbreaks and periods of remission. In most cases, relapses in Crohn's disease (CD) and in ulcerative colitis (UC) are unpredictable and despite effective medical treatment, a degree of subclinical inflammation may persist in the bowel wall, contributing to a significant risk of relapse.

Endoscopy has been used to monitor a disease but it is time-consuming, costly, invasive, and associated with certain risks of morbidity. Many patients are reluctant to undergo repeated endoscopic examinations, particularly when their disease is quiescent. Acute phase reactants have been used but their sensitivity and specificity in correlating to intestinal inflammatory activity are very low, and their capacity to predict disease relapse is poor and controversial. A number of fecal biomarkers have been evaluated for their utility for monitoring and predicting relapse in IBD but some of these biomarkers are also not specific.

In IBD, altered fecal microbiota signatures have been consistently reported which included a reduction in biodiversity with lower proportions of Firmicutes and increases in Proteobacteria and Bacteroidetes phylum members. In addition, disease remission and relapse are associated with microbial changes in both mucosal and fecal samples. In particular, a loss of species richness in Crohn's disease has been widely observed. Recently microbial biomarkers may differentiate between CD and UC. Furthermore, different microbial groups are associated with smoking habit and localization of the disease in CD and UC. It is however unclear whether changes in microbial profile including diversity and composition can predict disease relapse in IBD. We hypothesize that fecal microbial signatures in conjunction with fecal calprotectin may play a role in predicting relapse in IBD patients.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with Crohn's Disease
  • Aged ≥18 years old
  • Confirmed diagnosis of ileo-colonic Crohn's disease according to established clinical, endoscopic and histologic criteria
  • History of at least one flare with symptoms that required intervention within 24 months before screening
  • Stable doses of immunosuppressive agents for at least 3 months if these agents are required
  • In clinical remission for at least 3 months, defined as Harvey Bradshaw Index (HBI) score < 4
  • Written informed consent obtained
  • Patient with Ulcerative Colitis
  • Aged ≥18 years old
  • Have a confirmed diagnosis of ulcerative colitis according to established clinical, endoscopic and histologic criteria
  • History of at least one flare with symptoms that required intervention within 24 months before screening
  • On stable regimen of 5-ASA for at least 3 months
  • In clinical remission for at least 3 months defined as partial Mayo score ≤ 1
  • Written informed consent obtained

排除标准

  • Previous bowel surgery /stoma
  • On anti-TNF therapy
  • Malignant disease within 5 years
  • Use of probiotics, prebiotics or antibiotics in past 3 months
  • Terminal illness

结局指标

主要结局

Clinical relapse for UC patients

时间窗: 2 years

Defined as partial Mayo score of ≥ 5 points for UC and require a change in therapy.

Clinical relapse for CD patients

时间窗: 2 years

Defined as worsening of the symptoms, accompanied by HBI score of ≥ 8 points for CD and require a change in therapy.

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

Joseph JY SUNG

Profressor

Chinese University of Hong Kong

研究点 (1)

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