Rapid Urease Test for Helicobacter Pylori in Population Who Stop Proton Pump Inhibitor Less Than 2 Weeks Compared With Histology

NCT04233684 | Completed

• 1 other identifier: RP015
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with dyspepsia will have negative impact to their life and common cause is Helicobactor pylori infection. Rapid urease test is the easy available and rapid method to test the infection but the test may be interfered by proton pump inhibitor, bismuth or antibiotics .In general, patients with dyspepsia usually take proton pump inhibitor to relieve dyspepsia so those patients may not stop the drug before test the infection with rapid urease test. So author aims to measure the sensitivity of rapid urease test from biopsy of body, which H. pylori would migrate if the patients still take proton pump inhibitor and biopsy of antrum, which is standard location of biopsy compare to pathology for H. pylori in each sites in patients who do not stop taking proton pump inhibitor

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Sensitivity of rapid urease test for dectection of H.pylori from gastric antrum and body

  The sensitivity of rapid urease test for H.pylori diagnosis at antrum, body and both in patients stopping proton pump inhibitors less than 2 weeks

  24 hours after test by rapid urease test

Study Arms (1)

Study

EXPERIMENTAL

* Rapid urease test is the test for H. pylori infection by detect the change of pH by urease enzyme metabolism. * Pathologic test for H. pylori by H\&E stain and Giemsa stain * All tissues will be sent to immunohistochemistry as a gold standard

Diagnostic Test: rapid urease test

Interventions

rapid urease test DIAGNOSTIC_TEST

Rapid urease test is the test for H. pylori infection by detect the change of pH by urease enzyme metabolism. Pathologic test for H. pylori by H\&E stain and Giemsa stain Gold standard is a immunohistochemistry.

Also known as: pathologic test

Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with dyspepsia and have indication for esophagogastroscopy
• Patients who take PPI at least 2 weeks and stop the drug less than 2 weeks
• Age above 18 years old

You may not qualify if:

• Patients who diagnosed to have iron deficiency anemia and have signs of previously bleeding gastric ulcer
• Active upper gastrointestinal bleeding or recent bleeding
• previous gastric surgery
• patients who take bismuth or antibiotic in last 4 weeks
• Coagulopathy, INR\>1.5, Platelet \< 100,000
• gastric cancer
• Life expectancy less than 3 months
• Deny to participate in the study

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, State/Region/Province/District, 10330, Thailand

Location

Study Officials

• Pittayanon Pittayanon, MD

  King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The pathologists will be blinded for the result of endoscopic finding and rapid urease test.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: August 1, 2019
• Primary Completion: October 30, 2020
• Study Completion: February 1, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

TH (1)