Effect of PPIs on Stool DNA Test for H. Pylori

NCT07516262 | Recruiting DMC

• 1 other identifier: rjyg20260331
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Stool DNA Testing; Proton pump inhibitors

Outcome Measures

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.

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

Secondary Outcomes (1)

• Inter-Method Agreement Among Diagnostic Tests

  Baseline (for comparisons involving biopsy-based methods and serology) and 4 weeks after PPI discontinuation (for comparisons involving UBT)

Interventions

Proton Pump Inhibitor Discontinuation DRUG

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Central Study Contacts

Hong Lu, MD

CONTACT

+86-13611958022; hlu@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: May 1, 2025
• Primary Completion: May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

CN (1)