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CLINICAL RESEARCH STUDY

Prospective Multicenter Study Evaluating Fecal Calprotectin in Adult Acute Bacterial Diarrhea
Yogesh M. Shastri, MD, DNB,a,b Dominik Bergis, MD,c Nada Povse,a Volker Schäfer, MD,d Sarika Shastri, PhD,f Martin Weindel, MD,g Hans Ackermann, PhD,e Jürgen Stein, MD, PhDa
Department of Gastroenterology and Clinical Nutrition, Katharina Kasper Hospitals, Johann WolfgangGoethe-University, Frankfurt am Main, Germany, bKokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Mumbai, India, cDepartment of Medicine I, dDepartment of Medical Microbiology, eDepartment of Biomathematics, Johann Wolfgang Goethe-University Hospital, Frankfurt am Main, Germany, fInstitute of Biophysical Chemistry, Centre of Biomolecular Magnetic Resonance, Johann WolfgangGoethe-University, Frankfurt am Main, Germany, gLaboratory Walther, Weindel und Colleagues, Frankfurt am Main, Germany.
a

ABSTRACT BACKGROUND: Every year, about 2.2 million deaths occur worldwide due to diarrhea. Reliable diagnosis of patients with acute infectious diarrhea remains a formidable challenge to the clinicians. This is the first study reporting use of fecal calprotectin in diagnosing acutediarrhea. The aim was to compare the diagnostic accuracy of fecal calprotectin, fecal lactoferrin, and guaiac-based fecal occult blood test in a diverse group of consecutive patients with acute diarrhea in which routine bacterial stool cultures and cytotoxins for Clostridium difficile were performed. METHODS: This was a prospective case-control multicenter study from January 2004 until October 2007in 2383 consecutive patients with acute diarrhea. They provided stool samples for performing cultures. Patients with positive cultures and an equal number of matched controls with negative cultures underwent fecal occult blood test and calprotectin and lactoferrin assays. RESULTS: Calprotectin, lactoferrin, and fecal occult blood tests demonstrated sensitivity and specificity of 83% and 87%, 78%and 54%, and 38% and 85%, respectively, for diagnosing acute bacterial diarrhea. CONCLUSIONS: Calprotectin showed high correlation with bacteriologically positive infectious diarrhea compared with lactoferrin and fecal occult blood test. It may potentially revolutionize management algorithm for patients with acute diarrhea. As a screening test, calprotectin can generate results within hours tosupport presumptive diagnosis of infectious diarrhea, which can decide suitability of stool samples for culture. © 2008 Elsevier Inc. All rights reserved. • The American Journal of Medicine (2008) 121, 1099-1106 KEYWORDS: Diarrhea; Fecal calprotectin; Fecal lactoferrin; Fecal occult blood test (FOBT); Hemoccult test; Intestinal infection; Stool culture

There are about 4 billion cases of diarrheaworldwide, that is, about half the population of the world is affected with it once every year. Although mortality due to diarrhea has decreased significantly, it still contributes to more than 2.2 million deaths (4% of all deaths), mostly in the developing world, and 5% of health loss due to disability annually.1
Conflict of interest: JS has been a speaker for Immundiagnostik. None of the otherauthors have any financial or personal conflicts to declare. Requests for reprints should be addressed to Yogesh M. Shastri, MD, DNB, Department of Gastroenterology and Clinical Nutrition, Katharina Kasper Hospitals, Ginnheimer Straße 3, 60487 Frankfurt am Main, Germany. E-mail address: drshastri@gmail.com

Even the developed world is not spared its torments; it affects about 272 million individuals inthe US annually, amounting to nearly 0.9 million hospital admissions.2 A majority of cases of acute diarrhea, especially in the pediatric age group, are due to viruses and are self-limiting, requiring only fluid and electrolyte substitution. In these cases, diagnosing the etiology of acute diarrhea is not mandatory. Bacterial gastrointestinal (GI) infections too are an important cause of acute...