Fecal Calprotectin: Cheap Marker for Diagnosing Acute Infectious Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429325
Recruitment Status : Completed
First Posted : January 31, 2007
Last Update Posted : July 17, 2007
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:
Every year more than 4 billion cases of diarrhea occur worldwide culminating in about 2.5 million deaths, almost all in the developing nations. Reliable diagnosis of patients with acute infectious diarrhea which could be appropriately managed with antibiotics at presentation still remains a formidable challenge to the clinicians. To address this issue of predicting microbiological infectious etiology for diagnosing acute infectious diarrhea, we would evaluate stools from all patients with acute diarrhea with culture, Guaiac based fecal occult blood test (FOBT), Calprotectin and lactoferrin assays simultaneously. This would be the first study evaluating fecal calprotectin as a diagnostic marker in acute diarrhea

Condition or disease
Acute Diarrhea

Detailed Description:

There are about 4 billion cases of diarrhea worldwide i.e. about half the population of the world is affected with it once every year. Though the mortality because of it has reduced significantly still it contributes to more than 2.2 million deaths (4% of all deaths) and 5% of health loss due to disability annually. Most of these deaths are due to acute diarrhea, in the developing countries which rapidly causes dehydration unless adequately supplemented. Unlike many of the medical challenges, acute infectious diarrhea still remains a significant global health hazard. Adequate, appropriate treatment with proper antimicrobials not only shortens the morbidity, hospitalisation and costs to the society but also can be life saving in certain infectious diarrhea.

The biggest problem is the lack of accurate diagnostic modality to differentiate acute infections from non infectious diarrhea. Stool microscopy, Guaiac based fecal blood tests (hemoccult), lactoferrin assays and bacteriological culture have been used for this purpose till now. However none of these were of great help in the diagnostic algorithm of management of acute diarrhea. The gold standard to diagnose acute infectious diarrhea is of course the bacteriological culture. But its very expensive, time consuming and delays definite therapy. There is a need for something simple, cheap, fast and accurate to diagnose acute infectious diarrhea. In the present prospective study, we plan to evaluate the performance characteristics of fecal calprotectin in diverse group of patients referred to our hospitals. Its performance characteristics would be compared with that of lactoferrin and FOBT.

Study Type : Observational
Enrollment : 400 participants
Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Comparative Evaluation of Accuracy of Fecal Calprotectin, Lactoferrin and Occult Blood Testing (FOBT) in Predicting Microbiological Diagnosis for Acute Infectious Diarrhea: A Prospective Multicentre Double Blind Randomized Controlled Trial.
Study Start Date : January 2004
Study Completion Date : January 2007

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients having acute diarrhea i.e. 3 or more stools per day or stool weight exceeding 200 grams lasting less than 15 days

Exclusion Criteria:

Patients having the following diagnosis as they might have high calprotectin levels not only because of the diarrhea per se but may also be because of the underlying pathology itself.

  • Inflammatory bowel disease (Crohn’s disease, ulcerative disease)
  • Gastrointestinal malignancy (colorectal cancer, gastric cancer etc)
  • Cirrhosis of liver
  • Chronic pancreatitis
  • Currently on non steroidal anti inflammatory therapy
  • Younger than 1 year of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00429325

Laboratory Walther, Weindel & Colleagues
Frankfurt am Main, Hessen, Germany, D 60437
Department of Medicine I, Division of Gastroenterology and Clinical Nutrition, Johann Wolfgang Goethe-University Hospital
Frankfurt am Main, Hessen, Germany, D-60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Study Director: Jürgen M Stein, MD,PhD JW Goethe University Hospital, Frankfurt
Principal Investigator: Yogesh M Shastri, MD, DNB JW Goethe University Hospital, Frankfurt
Study Chair: Wolfgang F Caspary, MD JW Goethe University Hospital, Frankfurt Identifier: NCT00429325     History of Changes
Other Study ID Numbers: JWGUH-2
First Posted: January 31, 2007    Key Record Dates
Last Update Posted: July 17, 2007
Last Verified: February 2007

Keywords provided by Johann Wolfgang Goethe University Hospital:
acute infectious diarrhea,
fecal calprotectin,
stool culture,
hemoccult test,
Guaiac fecal occult blood test (FOBT)
fecal lactoferrin

Additional relevant MeSH terms:
Communicable Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Infective Agents