RecruitingNot Applicable

Effect of PPIs on Stool DNA Test for H. Pylori

China25 participantsStarted 2025-05-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Diagnostic Sensitivity and Specificity of Stool DNA Test Before and After PPI Discontinuation

Timeframe: Assessed at two time points: at baseline (after ≥4 weeks of PPI use) and at 4 weeks after PPI discontinuation

Trial details

NCT IDNCT07516262

SponsorShanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-30

Contact for this trial

Hong Lu, MD

+86-13611958022 hlu@sjtu.edu.cn

View on ClinicalTrials.gov More Helicobacter Pylori Infection trials