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DiarrheaNCT04491799

Fecal Calprotectin Level in Patients With Nosocomial Diarrhea

An observational study of Diarrhea and Calprotectin, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diarrhea, Calprotectin
What is being tested?
Fecal calprotectin
How many people
135 participants
Where
1 siteThailand
Study dates
1 Feb 2019to 30 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Inpatients in Siriraj hospital, Bangkok, Thailand

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Siriraj hospital

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: Fecal Calprotectin Level in Differentiating Between Inflammatory and Non-inflammatory Diarrhea 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.

Read the 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.

Being tested
Fecal calprotectin
Keywords
Nosocomial diarrhea, Fecal calprotectin
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal calprotectinDiagnostic 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.

Study groups in NCT04491799
Study groupRoleWhat they receive
Nosocomial diarrheaPatients who are hospitalized and develop diarrhea after 72 hours of hospitalization.
Receives: Diagnostic Test: Fecal calprotectin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fecal calprotectin levels

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

    Measured: 1 day

Secondary outcomes (1)

  1. Prognosis of hospitalized patients with nosocomial diarrhea.

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2020
  2. Study start1 Feb 2019
  3. Primary completion30 Sep 2020
  4. Study completion30 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04491799
Sponsor's protocol ID
Si056/2019
Status last verified
Apr 2021
First submitted
26 Apr 2020
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pawlowski SW, Warren CA, Guerrant R. Diagnosis and treatment of acute or persistent diarrhea. Gastroenterology. 2009 May;136(6):1874-86. doi: 10.1053/j.gastro.2009.02.072. Epub 2009 May 7.

    PubMed 19457416

  • Reintam Blaser A, Deane AM, Fruhwald S. Diarrhoea in the critically ill. Curr Opin Crit Care. 2015 Apr;21(2):142-53. doi: 10.1097/MCC.0000000000000188.

    PubMed 25692805

  • Chang SJ, Huang HH. Diarrhea in enterally fed patients: blame the diet? Curr Opin Clin Nutr Metab Care. 2013 Sep;16(5):588-94. doi: 10.1097/MCO.0b013e328363bcaf.

    PubMed 23799327

  • Bartlett JG. Clinical practice. Antibiotic-associated diarrhea. N Engl J Med. 2002 Jan 31;346(5):334-9. doi: 10.1056/NEJMcp011603. No abstract available.

    PubMed 11821511

  • Siciliano RF, Castelli JB, Randi BA, Vieira RD, Strabelli TM. Cytomegalovirus colitis in immunocompetent critically ill patients. Int J Infect Dis. 2014 Mar;20:71-3. doi: 10.1016/j.ijid.2013.11.008. Epub 2014 Jan 6.

    PubMed 24406737

  • Manabe YC, Vinetz JM, Moore RD, Merz C, Charache P, Bartlett JG. Clostridium difficile colitis: an efficient clinical approach to diagnosis. Ann Intern Med. 1995 Dec 1;123(11):835-40. doi: 10.7326/0003-4819-123-11-199512010-00004.

    PubMed 7486465

  • Crobach MJ, Dekkers OM, Wilcox MH, Kuijper EJ. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): data review and recommendations for diagnosing Clostridium difficile-infection (CDI). Clin Microbiol Infect. 2009 Dec;15(12):1053-66. doi: 10.1111/j.1469-0691.2009.03098.x.

    PubMed 19929972

  • van Rheenen PF, Van de Vijver E, Fidler V. Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis. BMJ. 2010 Jul 15;341:c3369. doi: 10.1136/bmj.c3369.

    PubMed 20634346

  • Menees SB, Powell C, Kurlander J, Goel A, Chey WD. A meta-analysis of the utility of C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin, and fecal lactoferrin to exclude inflammatory bowel disease in adults with IBS. Am J Gastroenterol. 2015 Mar;110(3):444-54. doi: 10.1038/ajg.2015.6. Epub 2015 Mar 3.

    PubMed 25732419

  • Mosli MH, Zou G, Garg SK, Feagan SG, MacDonald JK, Chande N, Sandborn WJ, Feagan BG. C-Reactive Protein, Fecal Calprotectin, and Stool Lactoferrin for Detection of Endoscopic Activity in Symptomatic Inflammatory Bowel Disease Patients: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2015 Jun;110(6):802-19; quiz 820. doi: 10.1038/ajg.2015.120. Epub 2015 May 12.

    PubMed 25964225

  • Whitehead SJ, Shipman KE, Cooper M, Ford C, Gama R. Is there any value in measuring faecal calprotectin in Clostridium difficile positive faecal samples? J Med Microbiol. 2014 Apr;63(Pt 4):590-593. doi: 10.1099/jmm.0.067389-0. Epub 2014 Jan 25.

    PubMed 24464697

  • Popiel KY, Gheorghe R, Eastmond J, Miller MA. Usefulness of Adjunctive Fecal Calprotectin and Serum Procalcitonin in Individuals Positive for Clostridium difficile Toxin Gene by PCR Assay. J Clin Microbiol. 2015 Nov;53(11):3667-9. doi: 10.1128/JCM.02230-15. Epub 2015 Sep 9.

    PubMed 26354814

  • Barbut F, Gouot C, Lapidus N, Suzon L, Syed-Zaidi R, Lalande V, Eckert C. Faecal lactoferrin and calprotectin in patients with Clostridium difficile infection: a case-control study. Eur J Clin Microbiol Infect Dis. 2017 Dec;36(12):2423-2430. doi: 10.1007/s10096-017-3080-y. Epub 2017 Aug 12.

    PubMed 28801865

  • Swale A, Miyajima F, Roberts P, Hall A, Little M, Beadsworth MB, Beeching NJ, Kolamunnage-Dona R, Parry CM, Pirmohamed M. Calprotectin and lactoferrin faecal levels in patients with Clostridium difficile infection (CDI): a prospective cohort study. PLoS One. 2014 Aug 29;9(8):e106118. doi: 10.1371/journal.pone.0106118. eCollection 2014.

    PubMed 25170963

  • Kim J, Kim H, Oh HJ, Kim HS, Hwang YJ, Yong D, Jeong SH, Lee K. Fecal Calprotectin Level Reflects the Severity of Clostridium difficile Infection. Ann Lab Med. 2017 Jan;37(1):53-57. doi: 10.3343/alm.2017.37.1.53.

    PubMed 27834066

Questions about this trial

What is this clinical trial studying?

An observational study of Diarrhea and Calprotectin, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fecal calprotectin levels (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04491799, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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