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Effect of PPIs on Stool DNA Test for H. Pylori

NCT07516262 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2026-06-05

No results posted yet for this study

Summary

This prospective, self-controlled clinical study aims to evaluate the impact of proton pump inhibitor (PPI) use on the accuracy of stool DNA testing for Helicobacter pylori (H. pylori) and to assess the applicability of this test in patients receiving PPI therapy. Patients requiring long-term PPI treatment and meeting the inclusion criteria were enrolled. After at least four weeks of PPI therapy, a stool DNA test was performed, along with collection of gastric mucosal samples via gastroscopy for tissue PCR, histology, and rapid urease testing, as well as H. pylori antibody detection. Subsequently, PPI treatment was discontinued for four weeks, after which a 13C-urea breath test and a repeat stool DNA test were conducted. By comparing the sensitivity, specificity, and consistency of stool DNA testing before and after PPI discontinuation, this study aims to characterize the interference of PPIs with the test results, thereby providing evidence to support improvements in H. pylori diagnostic methods.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Proton Pump Inhibitor Discontinuation

Participants underwent stool DNA testing and endoscopic evaluation after at least 4 weeks of continuous proton pump inhibitor (PPI) therapy. Subsequently, PPI treatment was discontinued for 4 weeks, after which a 13C-urea breath test and a repeat stool DNA test were performed. The intervention involves a 4-week washout period of PPI to assess its interference with stool DNA detection of Helicobacter pylori.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-05-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07516262 on ClinicalTrials.gov