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

The recruitment status of this study is unknown because the information has not been verified recently.
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
  Purpose

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
Helicobacter Pylori

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Effect of PPI treatment on helicobacter pylori diagnostic tests [ Time Frame: 1 month of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278901

Contacts
Contact: Vered Shabat, MD 972-3-9732798 ext 2798 veredsh3@clalit.org.il

Locations
Israel
Department of Gastroenterology, Rabin Medical Center Not yet recruiting
Petach Tikva, Israel, 49100
Contact: Vered Shabat, MD    972-3-9732798 ext 2798    veredsh3@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
  More Information

No publications provided

Responsible Party: Vered Shabat, MD, RMC
ClinicalTrials.gov Identifier: NCT01278901     History of Changes
Other Study ID Numbers: 20100300
Study First Received: January 16, 2011
Last Updated: January 18, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
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

ClinicalTrials.gov processed this record on September 16, 2014