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临床试验/NCT06623383
NCT06623383已完成不适用

Correlation of Fecal Calprotectin and Fecal Immunochemical Test in Determination of Endoscopic Activity in Inflammatory Bowel Disease Patients

Mahidol University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年10月1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
120
试验地点
1
主要终点
To study the correlation between fecal calprotectin and fecal immunochemical test for hemoglobin results and endoscopic scores from colonoscopy in patients with inflammatory bowel disease

研究概览

简要总结

Inflammatory bowel disease (IBD) patients often experience a long disease course with periods of remission and flare-ups. Currently, in addition to assessing disease stages based on symptoms, colonoscopy performed by specialized physicians is considered the standard for accurately monitoring disease activity. This procedure allows direct visualization of intestinal lesions. However, colonoscopy is complex, costly, carries the risk of complications, and is not suitable for frequent monitoring. This study aims to explore whether stool tests such as calprotectin and immunochemical tests, which are now standard for assessing disease activity in IBD, correlate with colonoscopy results. It also aims to assess the efficacy of these stool tests in determining whether the disease is in remission or active.

The objective of the study is to investigate the correlation and efficacy of stool test results, calprotectin and fecal immunochemical test, compared to colonoscopy in patients with IBD.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 18 years or older.
  • •Diagnosed with inflammatory bowel disease, either ulcerative colitis or Crohn's disease.
  • •Scheduled for colonoscopy for various indications, including:
  • •Follow-up after treatment to assess disease remission
  • •Clinical symptoms or laboratory results suggesting disease flare, such as increased abdominal pain, more frequent diarrhea, or elevated inflammatory markers in the blood
  • •Screening for colorectal cancer in patients with long-standing inflammatory bowel disease.

排除标准

  • •Patients who decline participation in the research project. Incomplete or unsuccessful colonoscopy.
  • •Failure to provide stool samples.
  • •Patients hospitalized for reasons unrelated to inflammatory bowel disease.

结局指标

主要结局

To study the correlation between fecal calprotectin and fecal immunochemical test for hemoglobin results and endoscopic scores from colonoscopy in patients with inflammatory bowel disease

时间窗: 1 year

To study the correlation between fecal calprotectin and fecal immunochemical test for hemoglobin results and endoscopic scores from colonoscopy in patients with inflammatory bowel disease.

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

Julajak Limsrivilai

Associate professor

Mahidol University

研究点 (1)

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