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Study on How Proton Pump Inhibitors Affect Stool DNA Testing for Helicobacter Pylori Infection Comparing Test Accuracy Before and After Stopping PPI Treatment

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-06-05

25

Participants Needed

1

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how proton pump inhibitors PPIs affect the accuracy of stool DNA tests used to detect Helicobacter pylori infection. This prospective, self-controlled clinical study focuses on patients who need long-term PPI treatment. The goal is to understand whether PPI use interferes with stool DNA test results and to improve diagnostic methods for H. pylori infection. Participants receive at least four weeks of continuous PPI therapy, after which a stool DNA test is done alongside gastric tissue collection via gastroscopy for PCR, histology, and rapid urease testing, plus H. pylori antibody detection. Then, PPI treatment is stopped for four weeks, followed by a 13C-urea breath test and another stool DNA test. This process allows comparison of test sensitivity, specificity, and consistency before and after stopping PPI use. During the study, patients undergo various tests including stool DNA tests, endoscopy with tissue sampling, antibody tests, and breath tests. Researchers measure changes in diagnostic accuracy at two key points after at least four weeks of PPI use and four weeks after stopping PPIs. The study also assesses how well different diagnostic methods agree. Participant involvement lasts through these testing periods to monitor the impact of PPI therapy on H. pylori detection.

CONDITIONS

Brief Title

Effect of PPIs on Stool DNA Test for H. Pylori

Research Team

H

Hong Lu, MD

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