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The Effect of PPI Therapy on the Result of Helicobacter Pylori Diagnostic Tests

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01278901
First received: January 16, 2011
Last updated: January 18, 2011
Last verified: January 2011

January 16, 2011
January 18, 2011
February 2011
February 2012   (final data collection date for primary outcome measure)
Effect of PPI treatment on helicobacter pylori diagnostic tests [ Time Frame: 1 month of therapy ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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The Effect of PPI Therapy on the Result of Helicobacter Pylori Diagnostic Tests
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STUDY PROTOCOL:

The study will include 30 patients ages 18-80y that had a gastroscopy for various reasons. The patients should not be on PPI therapy . If during the gastroscopy there are some pathologies that require a second look endoscopy after some weeks of therapy (ulcers or esophagitis), the investigators will repeat the gastroscopy within a month.

During the first gastroscopy a biopsy will be taken for histological examination and for a rapid urease test and an urea breath test will be done soon after the procedure.

If one of the tests is positive the investigators postulate that the Helicobacter pylori is actually present.

After the gastroscopy the patient is given a full dose of PPI (as indicated) and helicobacter tests are repeated in the next endoscopy (under PPI therapy) . Any positive test that become negative in the second endoscopy is considered false negative.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Cohort of helicobacter pylori positive patients undergoing EGD for different indications and not treated with PPI
Helicobacter Pylori
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Cohort of consecutive patients undergoing EGD treated with PPI
Patients positive for helicobacter pylori undergoing EGD, started on PPI therapy for a month, repeated diagnostic tests for Helicobacter pylori after a month of therapy (urease test, histology and breath test)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
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February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cohort of helicobacter pylori positive patients undergoing EGD for different indications and not treated with PPI-

Exclusion Criteria:

  • Patients younger than 18 years and older than 80 years
  • Severe background diseases
  • Previous eradicated helicobacter pylori infection
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01278901
20100300
No
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Vered Shabat, MD, RMC
Rabin Medical Center
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Rabin Medical Center
January 2011

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