- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00429325
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.
Study Overview
Status
Conditions
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
Enrollment
Contacts and Locations
Study Locations
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Hessen
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Frankfurt am Main, Hessen, Germany, D 60437
- Laboratory Walther, Weindel & Colleagues
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Frankfurt am Main, Hessen, Germany, D-60590
- Department of Medicine I, Division of Gastroenterology and Clinical Nutrition, Johann Wolfgang Goethe-University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Study Director: Jürgen M Stein, MD,PhD, JW Goethe University Hospital, Frankfurt
- Study Chair: Wolfgang F Caspary, MD, JW Goethe University Hospital, Frankfurt
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JWGUH-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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