HELICOBACTER PYLORI INFECTIONSNCT07533422
Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
A study testing Personalized treatment based on the results of fecal antimicrobial resistance gene testing and Conventional Quadruple Therapy in people with HELICOBACTER PYLORI INFECTIONS and Rescue Therapy for Helicobacter Pylori, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma. Guideline recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS, Rescue Therapy for Helicobacter Pylori
- What is being tested?
- Personalized treatment based on the results of fecal antimicrobial resistance gene testing and Conventional Quadruple Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 531 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① Age 18-70 years;
- Patients with Hp-positive chronic gastritis who have failed initial treatment, as confirmed by urea breath test or endoscopic biopsy;
- No use of PPIs, H2-receptor antagonists, antibiotics, or bismuth agents within 4 weeks;
- History of having received one previous, standardized Hp eradication therapy.
Who cannot join
- ① Use of antibiotics, bismuth agents within 4 weeks prior to treatment, or use of PPIs or H₂-receptor antagonists within 2 weeks prior to treatment;
- History of gastric or duodenal surgery;
- Concurrent presence of other serious conditions such as cardiac, hepatic, or renal dysfunction, malignant tumors, or other severe internal diseases;
- Allergy to any component of the study medications; ⑤ Pregnant or breastfeeding women; ⑥ Participation in other drug studies within 3 months prior to treatment; ⑦ Patients unable to accurately express their complaints or cooperate with the study investigators.
About this study
Official title: Multicenter, Randomized Controlled Study on Personalized Rescue Treatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma. Guideline recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. However, conventional susceptibility testing faces two major limitations: 1) reliance on invasive endoscopic biopsy for tissue acquisition, and 2) dependency on bacterial culture, which is complex and time-consuming. Fecal-based antimicrobial resistance gene testing overcomes these barriers, offering distinct advantages of being non-invasive, rapid and accurate, thereby improving patient compliance. This study aims to elucidate the diagnostic value of fecal nucleic acid testing for H. pyloriinfection and to evaluate the eradication rate and safety of tailored triple therapy regimens selected based on fecal resistance gene profiles.
Read the detailed description
Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma, and is classified as a Group I carcinogen by the World Health Organization. The "2022 Chinese Clinical Guidelines for the Treatment of Helicobacter pyloriInfection" recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. However, conventional susceptibility testing faces two major limitations: 1) reliance on invasive endoscopic biopsy for tissue acquisition, and 2) dependency on bacterial culture, which is complex and time-consuming. Fecal-based antimicrobial resistance gene testing overcomes these barriers, offering distinct advantages of being non-invasive (no endoscopy required), rapid (significantly shorter turnaround time), and accurate (direct detection of resistance genes), thereby improving patient compliance. This study aims to elucidate the diagnostic value of fecal nucleic acid testing for H. pyloriinfection and to evaluate the eradication rate and safety of tailored triple therapy regimens selected based on fecal resistance gene profiles.
- Being tested
- Personalized treatment based on the results of fecal antimicrobial resistance gene testing, Conventional Quadruple Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized treatment based on the results of fecal antimicrobial resistance gene testingDrug
Personalized treatment:
Patients sensitive to clarithromycin are assigned to the Clarithromycin Group (receiving a regimen of vonoprazan, amoxicillin, and clarithromycin); Patients resistant to clarithromycin but sensitive to levofloxacin are assigned to the Levofloxacin Group (receiving vonoprazan, amoxicillin, and levofloxacin); Patients resistant to both clarithromycin and levofloxacin are assigned to the Tetracycline Group (receiving vonoprazan, amoxicillin, and tetracycline).
The treatment duration for all groups is 10 days.
The specific dosages and administration methods are as follows:
Vonoprazan: 20 mg, twice daily (BID) Amoxicillin: 1.0 g, twice daily (BID) Clarithromycin: 0.5 g, twice daily (BID) Levofloxacin: 0.5 g, once daily (QD) Tetracycline: 0.5 g, three times daily (TID)
Conventional Quadruple TherapyDrug
Conventional Quadruple Therapy： Vonoprazan 20mg BID; Colloidal Bismuth Pectin 220mg BID; Amoxicillin 1.0g BID; tetracycline 0.5g TID. Treatment duration: 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Personalized treatment based on the results of fecal antimicrobial resistance gene testing |
| Control group | Active comparator | Not described Receives: Drug: Conventional Quadruple Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (1)
Adverse effect of the treatment
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start12 May 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 531 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533422
- Sponsor's protocol ID
- 2025-1670
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Controlled Study on Personalized Rescue Treatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
- ClinicalTrials.gov ID
- NCT07533422
- Acronym / sponsor ID
- 2025-1670
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 531 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 12 May 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 16 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.
Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma. Guideline recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. However, conventional susceptibility testing faces two major limitations: 1) reliance on invasive endoscopic biopsy for tissue acquisition, and 2) dependency on bacterial culture, which is complex and time-consuming. Fecal-based antimicrobial resistance gene testing overcomes these barriers, offering distinct advantages of being non-invasive, rapid and accurate, thereby improving patient compliance. This study aims to elucidate the diagnostic value of fecal nucleic acid testing for H. pyloriinfection and to evaluate the eradication rate and safety of tailored triple therapy regimens selected based on fecal resistance gene profiles.
Detailed description
Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma, and is classified as a Group I carcinogen by the World Health Organization. The "2022 Chinese Clinical Guidelines for the Treatment of Helicobacter pyloriInfection" recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. However, conventional susceptibility testing faces two major limitations: 1) reliance on invasive endoscopic biopsy for tissue acquisition, and 2) dependency on bacterial culture, which is complex and time-consuming. Fecal-based antimicrobial resistance gene testing overcomes these barriers, offering distinct advantages of being non-invasive (no endoscopy required), rapid (significantly shorter turnaround time), and accurate (direct detection of resistance genes), thereby improving patient compliance. This study aims to elucidate the diagnostic value of fecal nucleic acid testing for H. pyloriinfection and to evaluate the eradication rate and safety of tailored triple therapy regimens selected based on fecal resistance gene profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Personalized treatment based on the results of fecal antimicrobial resistance gene testing |
| Control group | Active comparator | Drug: Conventional Quadruple Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ① Age 18-70 years;
Key exclusion criteria (4 listed)
- ① Use of antibiotics, bismuth agents within 4 weeks prior to treatment, or use of PPIs or H₂-receptor antagonists within 2 weeks prior to treatment;
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 |
|---|---|---|
| Personalized treatment based on the results of fecal antimicrobial resistance gene testingPersonalized treatment: Patients sensitive to clarithromycin are assigned to the Clarithromycin Group (receiving a regimen of vonoprazan, amoxicillin, and clarithromycin); Patients resistant to clarithromycin but sensitive to levofloxacin are assigned to the Levofloxacin Group (receiving vonoprazan, amoxicillin, and levofloxacin); Patients resistant to both clarithromycin and levofloxacin are assigned to the Tetracycline Group (receiving vonoprazan, amoxicillin, and tetracycline). The treatment duration for all groups is 10 days. The specific dosages and administration methods are as follows: Vonoprazan: 20 mg, twice daily (BID) Amoxicillin: 1.0 g, twice daily (BID) Clarithromycin: 0.5 g, twice daily (BID) Levofloxacin: 0.5 g, once daily (QD) Tetracycline: 0.5 g, three times daily (TID) | Drug | Experimental group |
| Conventional Quadruple TherapyConventional Quadruple Therapy： Vonoprazan 20mg BID; Colloidal Bismuth Pectin 220mg BID; Amoxicillin 1.0g BID; tetracycline 0.5g TID. Treatment duration: 14 days. | Drug | Control group |
Primary outcome
H. pylori eradication rate
Time frame: From enrollment to the end of treatment at 6 weeks
1 secondary outcome
Adverse effect of the treatment
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized treatment based on the results of fecal antimicrobial resistance gene testing and Conventional Quadruple Therapy in people with HELICOBACTER PYLORI INFECTIONS and Rescue Therapy for Helicobacter Pylori, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
H. pylori eradication rate (time frame: From enrollment to the end of treatment at 6 weeks). 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 16 Apr 2026.