Fecal Calprotectin Level in Patients With Nosocomial Diarrhea

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT04491799

Collaborator

(none)

135

Enrollment

Location

20.9

Actual Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea Calprotectin	Diagnostic Test: Fecal calprotectin

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 Design

Study Type:

Observational

Actual Enrollment :

135 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Nosocomial diarrhea Patients who are hospitalized and develop diarrhea after 72 hours of hospitalization.	Diagnostic Test: Fecal calprotectin 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.

Arm

Intervention/Treatment

Nosocomial diarrhea

Patients who are hospitalized and develop diarrhea after 72 hours of hospitalization.

Diagnostic Test: Fecal calprotectin

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.

Outcome Measures

Primary Outcome Measures

Fecal calprotectin levels [1 day]
Compare fecal calprotectin levels in patients with inflammatory nosocomial diarrhea and non-inflammatory nosocomial diarrhea

Secondary Outcome Measures

Prognosis of hospitalized patients with nosocomial diarrhea. [30 days]
Correlation of fecal calprotectin levels and prognosis of hospitalized patients with nosocomial diarrhea.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Siriraj hospital	Bangkok		Thailand	10700

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator: Julajak Limsrivilai, MD, MSc, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Jan 24, 2019

More Information

Publications

Responsible Party:

Julajak Limsrivilai, Assist.Professor, Mahidol University

ClinicalTrials.gov Identifier:

NCT04491799

Other Study ID Numbers:

Si056/2019

First Posted:

Jul 29, 2020

Last Update Posted:

Apr 8, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Julajak Limsrivilai, Assist.Professor, Mahidol University

Nosocomial diarrhea

Fecal calprotectin

Additional relevant MeSH terms:

Diarrhea

Study Results

No Results Posted as of Apr 8, 2021