Effect of PPIs on Stool DNA Test for H. Pylori
ConditionHelicobacter Pylori Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai Jiao Tong University School of Medicine
About this trial
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
Qualifiers
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);
Disqualifiers
Prior H. pylori eradication therapy;
Pregnant or lactating women;
Acute gastrointestinal bleeding;
History of subtotal gastrectomy;
Trial design
Treatments tested in this trial
- Proton Pump Inhibitor Discontinuation
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov