Acute DiarrheaNCT00429325
Fecal Calprotectin: Cheap Marker for Diagnosing Acute Infectious Diarrhea
An observational study of Acute Diarrhea, run by Johann Wolfgang Goethe University Hospital at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Acute Diarrhea
- How many people
- 400 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2004to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients having acute diarrhea i.e. 3 or more stools per day or stool weight exceeding 200 grams lasting less than 15 days
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Laboratory Walther, Weindel & Colleagues
Frankfurt am Main, Hesse, D 60437
Department of Medicine I, Division of Gastroenterology and Clinical Nutrition, Johann Wolfgang Goethe-University Hospital
Frankfurt am Main, Hesse, D-60590
About this study
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.
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
Read the 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.
- Conditions
- Acute Diarrhea
- Keywords
- acute infectious diarrhea,, fecal calprotectin,, stool culture,, hemoccult test,, Guaiac fecal occult blood test (FOBT), fecal lactoferrin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJan 2004
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jürgen M Stein, MD,PhD, Study director, JW Goethe University Hospital, FrankfurtYogesh M Shastri, MD, DNB, Principal investigator, JW Goethe University Hospital, FrankfurtWolfgang F Caspary, MD, Study chair, JW Goethe University Hospital, Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429325
- Sponsor's protocol ID
- JWGUH-2
- Status last verified
- Feb 2007
- First submitted
- 30 Jan 2007
- Last updated
- 17 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00429325
- Acronym / sponsor ID
- JWGUH-2
- Conditions
- Acute Diarrhea
- Keywords
- acute infectious diarrhea,, fecal calprotectin,, stool culture,, hemoccult test,, Guaiac fecal occult blood test (FOBT), fecal lactoferrin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Jan 2007
- First posted
- 31 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients having acute diarrhea i.e. 3 or more stools per day or stool weight exceeding 200 grams lasting less than 15 days
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen M Stein, MD,PhD study director
JW Goethe University Hospital, Frankfurt
Yogesh M Shastri, MD, DNB principal investigator
JW Goethe University Hospital, Frankfurt
Wolfgang F Caspary, MD study chair
JW Goethe University Hospital, Frankfurt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Diarrhea, run by Johann Wolfgang Goethe University Hospital at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2007.