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

Helicobacter Pylori Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01278901
• Other study ID #: 20100300
• Status: Not yet recruiting
• Phase: N/A
• First received: January 16, 2011
• Last updated: January 18, 2011
• Start date: February 2011

Study information

• Verified date: January 2011
• Source: Rabin Medical Center
• Contact: Vered Shabat, MD
• Phone: 972-3-9732798
• Email: veredsh3[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Helicobacter Pylori

Locations

Country	Name	City	State
Israel	Department of Gastroenterology, Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of PPI treatment on helicobacter pylori diagnostic tests		1 month of therapy	No