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临床试验/NCT04491799
NCT04491799已完成不适用

Fecal Calprotectin Level in Differentiating Between Inflammatory and Non-inflammatory Diarrhea in Patients With Nosocomial Diarrhea

Mahidol University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2019年2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
135
试验地点
1
主要终点
Fecal calprotectin levels

研究概览

简要总结

Nosocomial diarrhea is a common problem.There are multiple ethiologies of nosocomial diarrhea in which can be divided into inflammatory and non inflammatory diarrhea. Fecal calprotectin is a good marker to identify inflammatory diarrhea in outpatient setting; for example, differentiating inflammatory bowel disease and irritable bowel syndrome. Its performance in inpatient setting has not been well established. This study aim to determine the efficacy of fecal calprotectin in distinguishing inflammatory nosocomial diarrhea from non-inflammatory nosocomial diarrhea.

详细描述

This is a prospective, cross-sectional, and observational study. The patients with nosocomial diarrhea whose stool samples are sent for stool examination and Clostridium difficile toxin by their treating physicians will be recruited. Their leftover stool samples will be kept at - 80 c and will be measured for calprotectin level at the end of study. The patients will be treated by their treating physicians. They will be classified into 2 groups - inflammatory and non-inflammatory diarrhea.

The inflammatory diarrhea will be defined if 1) positive for C. difficile toxin or 2) stool WBC more than 5/HPF or 3) inflammatory mucosa or ulceration noted on colonoscopy.

The noninflammatory diarrhea will be defined if 1)negative for C. difficile toxin and 2) no WBC on stool examination and 3) dramatic response to diet adjustment or 4) no mucosal inflammation or ulceration if colonoscopy is performed

The patients who do not respond to diet modification, but do not undergo colonoscopy will be excluded because the definite diagnosis cannot be made.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age more than 18 hear
  • Diarrhea more than 3 time per day after admitted in hospital more than 72 hours

排除标准

  • intraabdominal pressure more than 12 mmHg
  • patient on chemotherapy with neutropenia ,ANC less than 1,000/mm3
  • patients whose definite diagnosis cannot be obtained

结局指标

主要结局

Fecal calprotectin levels

时间窗: 1 day

Compare fecal calprotectin levels in patients with inflammatory nosocomial diarrhea and non-inflammatory nosocomial diarrhea

次要结局

  • Prognosis of hospitalized patients with nosocomial diarrhea.(30 days)

研究者

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

Julajak Limsrivilai

Assist.Professor

Mahidol University

研究点 (1)

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