Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing (NCT07533422) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
531 participantsStarted 2026-05-12
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
H. pylori eradication rate
Timeframe: From enrollment to the end of treatment at 6 weeks
Trial details
NCT IDNCT07533422
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University