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
This trial does not accept healthy volunteersQualifiers
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 population
Patients aged 18-80 years requiring PPI therapy for gastritis or peptic ulcer disease, with no prior H. pylori eradication therapy, and confirmed H. pylori infection (≥2 positive among antibody, histology, and RUT). Exclusion criteria include pregnancy, lactation, acute gastrointestinal bleeding, subtotal gastrectomy, severe organ dysfunction, recent antibiotic use (within 4 weeks), substance abuse, and conditions affecting compliance or safety. All participants provide written informed consent.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Proton Pump Inhibitor Discontinuation
DrugParticipants 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in Diagnostic Sensitivity and Specificity of Stool DNA Test Before and After PPI Discontinuation
The sensitivity and specificity of stool DNA testing for Helicobacter pylori detection will be assessed under two conditions: (1) after at least 4 weeks of continuous proton pump inhibitor (PPI) therapy, and (2) after a 4-week PPI washout period. The reference standard comprises gastric mucosal biopsy results (histology, tissue PCR, and rapid urease test) combined with H. pylori antibody testing during the PPI-on phase, and 13C-urea breath test during the PPI-off phase. The primary outcome is the difference in sensitivity and specificity between the two conditions.
Time frame
Assessed at two time points: at baseline (after ≥4 weeks of PPI use) and at 4 weeks after PPI discontinuationSecondary outcomes
1
Inter-Method Agreement Among Diagnostic Tests
The level of agreement (kappa coefficient) among stool DNA test, gastric biopsy-based methods (histology, PCR, RUT), H. pylori antibody test, and 13C-urea breath test. This outcome assesses the overall concordance of diagnostic results across different testing modalities under varying PPI conditions.
Time frame
Baseline (for comparisons involving biopsy-based methods and serology) and 4 weeks after PPI discontinuation (for comparisons involving UBT)Sponsors and contacts
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Source ClinicalTrials.gov