Fecal Calprotectin: Cheap Marker for Diagnosing Acute Infectious Diarrhea

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00429325
First received: January 30, 2007
Last updated: July 16, 2007
Last verified: February 2007

January 30, 2007
July 16, 2007
January 2004
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Complete list of historical versions of study NCT00429325 on ClinicalTrials.gov Archive Site
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Fecal Calprotectin: Cheap Marker for Diagnosing Acute Infectious Diarrhea
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.

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

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.

Observational
Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
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Acute Diarrhea
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
January 2007
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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
Both
18 Months and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00429325
JWGUH-2
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Johann Wolfgang Goethe University Hospitals
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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
Johann Wolfgang Goethe University Hospitals
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP