RecruitingNCT07516262

Effect of PPIs on Stool DNA Test for H. Pylori

Effect of Proton Pump Inhibitors on Stool DNA Detection of Helicobacter Pylori: A Prospective Clinical Study

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

25 participants

Start Date

May 1, 2025

Study Type

OBSERVATIONAL

Conditions

Helicobacter Pylori Infection

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

Male or female patients aged 18-80 years;
No prior H. pylori eradication therapy;
Patients requiring proton pump inhibitor (PPI) therapy in the near future due to gastritis, peptic ulcer disease, or other indicated conditions;
Patients with at least two positive results among H. pylori antibody test, histology, and rapid urease test (RUT);
Provision of signed informed consent and being informed of the specific study protocol.

Exclusion Criteria10

Prior H. pylori eradication therapy;
Pregnant or lactating women;
Acute gastrointestinal bleeding;
History of subtotal gastrectomy;
Severe dysfunction of vital organs (heart, liver, kidney, lungs, etc.) or congenital diseases, such as class IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.;
Refusal of enrollment by the guardian or the patient;
Alcohol and/or drug abuse (addiction or dependence), or poor compliance as judged by the investigator;
Individuals without legal capacity or with impaired insight;
Abnormal neurological signs on physical examination;
Use of oral antibiotics with bactericidal activity against H. pylori within 4 weeks.

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Interventions

DRUGProton 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.