NCT07516262 Effect of PPIs on Stool DNA Test for H. Pylori
| NCT ID | NCT07516262 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Helicobacter Pylori Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2025-05-01 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07516262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Helicobacter Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07516262 currently recruiting?
Yes, NCT07516262 is actively recruiting participants. Contact the research team at hlu@sjtu.edu.cn for enrollment information.
Where is the NCT07516262 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07516262 clinical trial?
NCT07516262 is sponsored by Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 25 participants.