Targeted versus standard therapy for stubborn H. pylori infections
Official title: Comparison of Susceptibility Testing Guided Versus Empirical Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial
Run by National Taiwan University Hospital · NCT04332848 · Data updated 2026-11-12
This trial will test whether choosing antibiotics based on lab susceptibility results works better than standard empirical therapy for adults whose H. pylori infection did not clear after at least two prior treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Enrollment | 360 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | July 28, 2020 |
| Main results expected | December 2025 |
| Study ends | December 2026 |
| Registry record updated | August 29, 2025 |
| Trial ID | NCT04332848 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20 years or older who have failed at least two prior H. pylori eradication regimens are eligible.
✕Probably not a fit
People who have not yet undergone two eradication attempts, cannot provide gastric samples for susceptibility testing, or are allergic to study antibiotics are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, open-label, randomized Phase 4 trial enrolling 360 adults with at least two prior H. pylori eradication failures. Patients will be randomized to susceptibility-guided therapy or to an empirical third-line regimen. H. pylori isolates will undergo agar dilution testing to determine minimum inhibitory concentrations for levofloxacin, tetracycline, rifabutin, and clarithromycin to guide antibiotic selection in the guided arm. The primary outcome is eradication rate by intention-to-treat, and secondary analyses will examine long-term changes in gut microbiota, antibiotic resistance, and metabolic markers.
Why it matters
Potential benefit: If successful, this approach could raise cure rates for people with refractory H. pylori and help avoid unnecessary use of ineffective antibiotics.
How similar studies have gone: Previous randomized trials and meta-analyses have suggested susceptibility-guided therapy can improve eradication rates in refractory H. pylori, though results depend on local resistance patterns.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.
Where it's running
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National Taiwan University Hospital
Taipei, Taiwan Recruiting
Study contacts
- Principal investigator: Mei-Jyh Chen, MD — National Taiwan University Hospital
- Study coordinator: Mei-Jyh Chen
- Email: migichen@ntuh.gov.tw
- Phone: 886-2-23123456
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.