Fecal Calprotectin: Cheap Marker for Diagnosing Acute Infectious Diarrhea
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|ClinicalTrials.gov Identifier: NCT00429325|
Recruitment Status : Completed
First Posted : January 31, 2007
Last Update Posted : July 17, 2007
|Condition or disease|
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|
|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|
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 ClinicalTrials.gov 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|
|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|