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Fecal Calprotectin Level in Patients With Nosocomial Diarrhea

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04491799
Enrollment
135
Registered
2020-07-29
Start date
2019-02-01
Completion date
2020-10-30
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea, Calprotectin

Keywords

Nosocomial diarrhea, Fecal calprotectin

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.

Interventions

DIAGNOSTIC_TESTFecal 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.

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fecal calprotectin levels1 dayCompare fecal calprotectin levels in patients with inflammatory nosocomial diarrhea and non-inflammatory nosocomial diarrhea

Secondary

MeasureTime frameDescription
Prognosis of hospitalized patients with nosocomial diarrhea.30 daysCorrelation of fecal calprotectin levels and prognosis of hospitalized patients with nosocomial diarrhea.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026