- Design
- randomised controlled single-centre trial, open comparison of two regimens
- Population
- 79 treatment-naive Korean adults with Helicobacter pylori infection
- Primary outcome
- eradication confirmed by 13C-urea breath test
- Effect
- 80.0% (32/40) with 7-day fexuprazan triple therapy vs 82.1% (32/39) with 14-day rabeprazole triple therapy (p=1.000, full analysis set)
Potassium-competitive acid blockers raise gastric pH faster and more consistently than proton pump inhibitors, which is the rationale for using them to shorten eradication regimens. This single-centre Korean trial randomised 79 treatment-naive patients to seven days of fexuprazan 40 mg with amoxicillin 1 g and clarithromycin 500 mg twice daily, or fourteen days of the same antibiotics with rabeprazole 20 mg.
Eradication, by 13C-urea breath test, was 80.0% with the seven-day fexuprazan regimen and 82.1% with the fourteen-day rabeprazole regimen in the full analysis set (83.8% and 88.9% per protocol). Adverse events were common and similar in both arms, around two-thirds of patients. In clarithromycin-susceptible strains, eradication rose to 93.1% and 87.1% respectively.
The comparison is the least interesting part. Both arms fell below the 90% eradication that is the accepted benchmark for a first-line regimen, and the reason is visible in the susceptibility split: performance was fine where clarithromycin worked and poor where it did not. A trial of 79 patients cannot establish non-inferiority of anything, and it was not designed to — but it does illustrate that halving the duration is not the variable that determines success.
- Clarithromycin-based triple therapy should not be used empirically where local clarithromycin resistance exceeds about 15%, which includes most of India.
- Bismuth quadruple therapy remains the sensible empirical first line in a high-resistance setting.
- Confirm eradication with a urea breath test or stool antigen at least four weeks after treatment and two weeks off acid suppression — not serology.
- A shorter course helps adherence, but adherence was not the limiting factor here; resistance was.
Why it matters
It is a reminder that eradication regimens fail on resistance, and that shortening a failing regimen does not fix it.
Don't overread it
Seventy-nine patients at a single centre cannot establish that the shorter regimen is as good; the trial was too small for that conclusion.
The statistics, in plain English
With roughly 40 patients per arm, a difference of two percentage points is indistinguishable from no difference and equally indistinguishable from a difference of fifteen — the p values of 1.000 and 0.737 reflect the absence of power, not the presence of equivalence. The susceptibility-stratified numbers are drawn from subgroups of 29 and 31 patients, so a 93% versus 87% comparison there rests on a handful of events either way.
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