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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01278901

Enrollment

Registered

2011-01-19

Start date

2011-02-28

Completion date

Unknown

Last updated

2011-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Effect of PPI treatment on helicobacter pylori diagnostic tests	1 month of therapy

Countries

Israel

Contacts

Primary ContactVered Shabat, MD

veredsh3@clalit.org.il972-3-9732798

Outcome results