Helicobacter Pylori InfectionNCT07516262
Effect of PPIs on Stool DNA Test for H. Pylori
An observational study of Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Proton Pump Inhibitor Discontinuation
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Effect of Proton Pump Inhibitors on Stool DNA Detection of Helicobacter Pylori: A Prospective Clinical Study
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
- Being tested
- Proton Pump Inhibitor Discontinuation
- Keywords
- Helicobacter pylori, Stool DNA Testing, Proton pump inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Pump Inhibitor DiscontinuationDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (for comparisons involving biopsy-based methods and serology) and 4 weeks after PPI discontinuation (for comparisons involving UBT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jun 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516262
- Sponsor's protocol ID
- rjyg20260331
- Status last verified
- Aug 2026
- First submitted
- 31 Mar 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proton Pump Inhibitors on Stool DNA Detection of Helicobacter Pylori: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07516262
- Acronym / sponsor ID
- rjyg20260331
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Stool DNA Testing, Proton pump inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Pump Inhibitor DiscontinuationParticipants 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. | Drug | – |
Primary outcome
Change in Diagnostic Sensitivity and Specificity of Stool DNA Test Before and After PPI Discontinuation
Time frame: Assessed at two time points: at baseline (after ≥4 weeks of PPI use) and at 4 weeks 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.
1 secondary outcome
Inter-Method Agreement Among Diagnostic Tests
Time frame: Baseline (for comparisons involving biopsy-based methods and serology) and 4 weeks after PPI discontinuation (for comparisons involving UBT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diagnostic Sensitivity and Specificity of Stool DNA Test Before and After PPI Discontinuation (time frame: Assessed at two time points: at baseline (after ≥4 weeks of PPI use) and at 4 weeks after PPI discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.