Actively Recruiting
Effect of Proton Pump Inhibitors on Stool DNA Detection of Helicobacter Pylori A Prospective Clinical Study
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-06-05
25
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how proton pump inhibitors (PPIs) affect the accuracy of stool DNA tests used to detect Helicobacter pylori infection. This prospective, self-controlled clinical study focuses on patients who need long-term PPI treatment. The goal is to understand whether PPI use interferes with stool DNA test results and to improve diagnostic methods for H. pylori infection. Participants receive at least four weeks of continuous PPI therapy, after which a stool DNA test is done alongside gastric tissue collection via gastroscopy for PCR, histology, and rapid urease testing, plus H. pylori antibody detection. Then, PPI treatment is stopped for four weeks, followed by a 13C-urea breath test and another stool DNA test. This process allows comparison of test sensitivity, specificity, and consistency before and after stopping PPI use. During the study, patients undergo various tests including stool DNA tests, endoscopy with tissue sampling, antibody tests, and breath tests. Researchers measure changes in diagnostic accuracy at two key points: after at least four weeks of PPI use and four weeks after stopping PPIs. The study also assesses how well different diagnostic methods agree. Participant involvement lasts through these testing periods to monitor the impact of PPI therapy on H. pylori detection.
CONDITIONS
Brief 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 Helicobacter pylori eradication therapy
- Require proton pump inhibitor (PPI) therapy for gastritis, peptic ulcer disease, or other indicated conditions
- Have at least two positive results among H. pylori antibody test, histology, and rapid urease test
- Provide signed informed consent and understand the study protocol
You will not qualify if you...
- Prior Helicobacter 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 patient or guardian
- Alcohol or drug abuse, or poor compliance
- Individuals without legal capacity or impaired insight
- Abnormal neurological signs on physical examination
- Use of oral antibiotics active against H. pylori within 4 weeks prior
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 4 weeks of continuous PPI therapy before discontinuation
Participants undergo stool DNA testing and endoscopic evaluation after at least 4 weeks of continuous proton pump inhibitor (PPI) therapy to assess Helicobacter pylori presence.
1 visit for stool DNA testing and endoscopic evaluation
Duration - 4 weeks
Participants discontinue PPI treatment for a 4-week washout period to evaluate its effect on stool DNA detection of Helicobacter pylori.
Participants discontinue PPI at home with no required visits during this period
Duration - 1 day for testing after 4-week discontinuation
After PPI discontinuation, participants undergo a 13C-urea breath test and repeat stool DNA testing to assess changes in Helicobacter pylori detection.
1 visit for 13C-urea breath test and repeat stool DNA test
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
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
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