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

Clalit Health Services

Status: Unknown

Conditions: Helicobacter Pylori

Study type: Observational

Funder types: Other

Identifiers

NCT01278901

20100300

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

30 participants in 1 patient group

Cohort of consecutive patients undergoing EGD treated with PPI

Description:

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)