Background: Potassium-competitive acid blockers (P-CAB) are recommended for the treatment of Helicobacter pylori infections, but dual therapy of P-CAB with amoxicillin has been poorly studied. The current study compared the efficacy, adverse reactions, compliance, and effects on gut microbiota of 14-day vonoprazan-amoxicillin (VA) dual therapy with esomeprazole, bismuth potassium citrate, amoxicillin, and metronidazole (EBAM) quadruple therapy in treatment-naive patients with H. pylori. Materials and Methods: This was a multicenter, open-label, randomized, and controlled, non-inferiority study. Patients (n = 194) enrolled from six centers were randomly divided into either the VA or EBAM group. H. pylori eradication was determined using 13 C urea breath tests (UBT) 4-6 weeks post-treatment. Fecal samples were collected, and gut microbial populations were analyzed by 16S rDNA and metagenomic sequencing technology.Results: Eradication rates of H. pylori in the VA and EBAM groups were 88.7% and 91.8%, respectively, according to intention-to-treat (ITT) analysis; 95.6% and 96.7% with per-protocol (PP) analysis; and 94.5% and 96.7% with modified ITT (mITT) analysis (all p > 0.05). The incidence of adverse reactions in the VA group was significantly lower compared to the EBAM group, and compliance within both groups was good.There was no difference in α-diversity or microbial composition in the VA and EBAM groups at one-month post-treatment compared to baseline, except for a markedly reduced abundance of Bacteroides in the EBAM group. Conclusion:VA therapy achieved excellent eradication rates with low adverse reactions, good compliance, and little impact on gut microbiota. VA therapy should be recommended as a first-line treatment against H. pylori.

Background Inconsistent eradication rates for Helicobacter pylori have been reported worldwide with dual therapy, perhaps owing to the difference in dose administration and treatment duration. This retrospective study aimed to determine whether high‐dose dual therapy (HDDT) with different regimens leads to different eradication rates. The study compares the efficacy and safety of HDDT 10‐day vs 14‐day and investigates the factors that might affect the eradication rates. Materials and Methods Two comparable treatment groups were based on propensity score matching (PSM). Patients were divided into two groups based on the therapy they underwent: 10‐day HDDT and 14‐day HDDT (20 mg esomeprazole and 750 mg amoxicillin, administered four times daily). The eradication rates, adverse events (AEs), patient compliance, CYP2C19 gene polymorphisms, and antibiotic resistance rates of the two groups were compared. Results The intention to treat (ITT) analysis showed that the eradication rates for 10‐day and 14‐day groups were 78.4% (95% CI 69.6%–87.2%) and 89.7% (95% CI 83.3%–96.2%; p = .039), respectively, while the per‐protocol (PP) eradication rates were 80.0% (95% CI 71.3%–88.7%) and 92.9% (95% CI 87.4%–98.5%; p = .014), respectively. The corresponding drug‐related AEs were 6.8% (6/88) and 5.7% (5/88; p = .755). No significant differences were observed between the compliance rates of the two groups. The CYP2C19 gene polymorphism had no effect on the eradication rates of the two groups. Conclusion The results showed that the 14‐day HDDT affords a higher H. pylori eradication rate than the 10‐day HDDT.

Background: A high-dose proton pump inhibitor (PPI)-amoxicillin dual therapy has been investigated for treatment of patients with Helicobacter pylori ( H. pylori) infection. Currently, the efficacy of this dual therapy remains inconclusive, with controversial findings from various single-center clinical trials. Objectives: To assess the efficacy and safety of high-dose dual therapy (HDDT) compared with the bismuth-containing quadruple therapy (BQT) in treatment-naive patients with H. pylori infection. Design: A multicenter, open-label, randomized controlled clinical trial. Methods: Three hundred and forty treatment-naïve patients with H. pylori infection were prospectively recruited from seven participating hospitals. The enrolled patients were randomized into one of two treatment groups: the HDDT group (esomeprazole, 20 mg four times daily; amoxicillin, 750 mg four times daily) and the BQT group (esomeprazole, 20 mg, twice daily; bismuth potassium citrate, 600 mg, twice daily; amoxicillin, 1 g, twice daily; metronidazole, 400 mg, four times daily). The primary outcome was eradication rate, and secondary outcomes were safety and patient compliance. Results: The eradication rates in the HDDT group versus the BQT group were 86.47% versus 87.06% on intention-to-treat (ITT) analysis, 91.88% versus 92.50% on modified ITT (MITT) analysis, and 91.77% versus 93.04% on per-protocol (PP) analysis, with no significant differences between the two groups. The patient compliance rates in the HDDT group versus the BQT group were 97.02% versus 95.86%, and no significant difference was found between the two groups. Notably, the HDDT group exhibited significantly lower incidence in the drug-induced adverse events (AEs) compared to the BQT group (16.67% versus 47.94%). Conclusion: HDDT is equally efficacious in eradicating H. pylori infection and resulted in good patient compliance and safety compared with BQT. These findings provide evidence in support of HDDT as a first-line treatment for H. pylori infection. Registration: This clinical trial was registered at The Chinese Clinical Trial Registry (trial registration number: ChiCTR2000039096).