Clincosm LogoSign in Get a demo

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

Sponsor
Rabin Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01278901
Collaborator
(none)
30
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Feb 1, 2011
    Anticipated Primary Completion Date :
    Feb 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. Effect of PPI treatment on helicobacter pylori diagnostic tests [1 month of therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastroenterology, Rabin Medical Center Petach Tikva Israel 49100

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01278901
    Other Study ID Numbers:
    • 20100300
    First Posted:
    Jan 19, 2011
    Last Update Posted:
    Jan 19, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    helicobacter pylori
    urease test
    13C-UBT
    the focus of the study is to evaluate a possible effect of PPI therapy on Helicobacter pylori diagnostic tests

    Study Results

    No Results Posted as of Jan 19, 2011