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OpenTrials
Completed

NCT Number: NCT04491799

Fecal Calprotectin Level in Patients With Nosocomial Diarrhea

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Siriraj hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

fecal calprotectin

Diagnostic Test

Fecal calprotectin is a protein found in human neutrophils, and it is released during active periods of inflammation of intestine. The sensitivity and specificity has been reported at 93% and 96%, respectively in differentiating inflammatory bowel disease from irritable bowel syndrome in outpatient setting.

Primary outcomes

  1. Fecal calprotectin levels

    Time frame: 1 day

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

Secondary outcomes

  1. Prognosis of hospitalized patients with nosocomial diarrhea.

    Time frame: 30 days

    Correlation of fecal calprotectin levels and prognosis of hospitalized patients with nosocomial diarrhea.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2020
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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