Peptic EsophagitisNCT00920400
Diagnostic Value of Fecal Calprotectin in Disorders of the Upper Gastrointestinal Tract
An observational study of Peptic Esophagitis and Peptic Ulcer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Fecal calprotectin is a very sensitive non-invasive inflammation marker in the detection of inflammatory bowel disease and, to a lesser degree, has also proven to be useful in adenomatous polyps, neoplasias, and infectious gastroenteritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Esophagitis, Peptic Ulcer, Functional Dyspepsia
- How many people
- 287 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2008to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 consecutive patients undergoing upper endoscopy at the Department of Gastroenterology \& Hepatology at the University Hospital Basel
Who may be able to join
- All patients referred for upper gastrointestinal endoscopy for any reason
- Older than 18 years
Who cannot join
- Patients who are not able to provide informed consent
- Patients who are not able to provide a stool sample
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Gastroenterology & Hepatology
Basel, Basel-Stand, 4031
About this study
Official title: Value of Fecal Calprotectin in Upper Gastrointestinal Disease
Fecal calprotectin is a very sensitive non-invasive inflammation marker in the detection of inflammatory bowel disease and, to a lesser degree, has also proven to be useful in adenomatous polyps, neoplasias, and infectious gastroenteritis. Elevated calprotectin levels can also be found in patients with lesion only in the upper gastrointestinal tract. However, the diagnostic value of calprotectin has never been tested in this setting. The aim of the study is therefore to determine the diagnostic value of fecal calprotectin in patients with diseases of the upper gastrointestinal tract.
- Conditions
- Peptic Esophagitis, Peptic Ulcer, Functional Dyspepsia, Irritable Bowel Syndrome, Inflammatory Bowel Diseases
- Medical subject headings
- Esophagitis, Peptic, Peptic Ulcer, Irritable Bowel Syndrome, Inflammatory Bowel Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic EsophagitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Beglinger, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920400
- Sponsor's protocol ID
- CALPROTECT
- Status last verified
- Jan 2010
- First submitted
- 12 Jun 2009
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Fecal Calprotectin in Upper Gastrointestinal Disease
- ClinicalTrials.gov ID
- NCT00920400
- Acronym / sponsor ID
- CALPROTECT
- Conditions
- Peptic Esophagitis, Peptic Ulcer, Functional Dyspepsia, Irritable Bowel Syndrome, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Jun 2009 (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.
Fecal calprotectin is a very sensitive non-invasive inflammation marker in the detection of inflammatory bowel disease and, to a lesser degree, has also proven to be useful in adenomatous polyps, neoplasias, and infectious gastroenteritis. Elevated calprotectin levels can also be found in patients with lesion only in the upper gastrointestinal tract. However, the diagnostic value of calprotectin has never been tested in this setting. The aim of the study is therefore to determine the diagnostic value of fecal calprotectin in patients with diseases of the upper gastrointestinal tract.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 consecutive patients undergoing upper endoscopy at the Department of Gastroenterology \& Hepatology at the University Hospital Basel
Key inclusion criteria (2 listed)
- All patients referred for upper gastrointestinal endoscopy for any reason
- Older than 18 years
Key exclusion criteria (2 listed)
- Patients who are not able to provide informed consent
- Patients who are not able to provide a stool sample
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 12 Jan 2010.
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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.
Christoph Beglinger, Prof. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peptic Esophagitis and Peptic Ulcer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 inclusion and 2 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 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 12 Jan 2010.