Actively Recruiting
Effect of PPIs on Stool DNA Test for H. Pylori
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-04-07
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effect of PPIs on Stool DNA Test for H. Pylori
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18-80 years
- No prior H. pylori eradication therapy
- Patients requiring proton pump inhibitor (PPI) therapy due to gastritis, peptic ulcer disease, or other indicated conditions
- At least two positive results among H. pylori antibody test, histology, and rapid urease test
- Signed informed consent and understanding of the study protocol
You will not qualify if you...
- Prior H. pylori eradication therapy
- Pregnant or lactating women
- Acute gastrointestinal bleeding
- History of subtotal gastrectomy
- Severe dysfunction of vital organs or congenital diseases such as class IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease
- Refusal of enrollment by guardian or patient
- Alcohol or drug abuse or poor compliance
- Lack of legal capacity or impaired insight
- Abnormal neurological signs on physical exam
- Use of oral antibiotics active against H. pylori within 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
H
Hong Lu, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here