Fecal Calprotectin Level in Patients With Nosocomial Diarrhea

Completed

• Conditions: Diarrhea; Calprotectin
• Interventions: Diagnostic Test: Fecal calprotectin

• Registration Number: NCT04491799
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-29
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nosocomial diarrhea	Fecal calprotectin	Patients who are hospitalized and develop diarrhea after 72 hours of hospitalization.

Primary Outcome Measures

Name	Time	Method
Fecal calprotectin levels	1 day	Compare fecal calprotectin levels in patients with inflammatory nosocomial diarrhea and non-inflammatory nosocomial diarrhea

Secondary Outcome Measures

Name	Time	Method
Prognosis of hospitalized patients with nosocomial diarrhea.	30 days	Correlation of fecal calprotectin levels and prognosis of hospitalized patients with nosocomial diarrhea.

Trial Locations

Locations (1)

Siriraj hospital; 🇹🇭 Bangkok, Thailand