Introduction

Increasing resistance to antibiotics represents a significant challenge for the successful eradication of Helicobacter pylori (H. pylori). Therefore, there is a growing need to find novel modalities to improve treatment outcomes.

Aims & Methods

This study aimed to assess the efficacy and safety of levofloxacin- or moxifloxacin-containing nitazoxanide-based regimens for eradicating H. pylori as first- and second-line therapies. Patients with dyspeptic symptoms and a positive H. pylori antigen test in the stool were eligible for inclusion in this study. Naïve patients were randomized into three groups according to treatment regimens: levofloxacin, nitazoxanide, doxycycline, and lansoprazole (LNDL); moxifloxacin, nitazoxanide, doxycycline, and lansoprazole (MNDL); or amoxicillin, clarithromycin, and lansoprazole (ACL) for 14 days. Treatment-experienced patients received the LNDL or MNDL regimen. H. pylori eradication was confirmed by stool antigen testing at least 4 weeks after the cessation of therapy.

Results

In naïve patients, eradication rates were significantly greater by intention to treat (ITT) analysis in patients treated with the LNDL regimen (83.3%) than in those treated with standard triple therapy (ACL) (59.2%). According to the per-protocol analysis (PP), both the LNDL and MNDL regimens had significantly greater eradication rates (87.7% and 81.6%, respectively) than did the ACL regimen (60.9%). Regarding treatment-experienced patients, eradication rates were comparable for the LNDL and MNDL regimens in both ITT (65.9% and 77.5%, respectively) and PP analyses (72.5% and 82.7%, respectively). All treatment regimens were well tolerated.

Table 1 Eradication Rates of Helicobacter pylori infection in treatment-naïve patients

Conclusion

levofloxacin- and moxifloxacin-containing nitazoxanide-based regimens exhibit substantial efficacy for the eradication of both naïve and resistant H. pylori infections over a 14-day course with a considerable safety profile.

Disclosure

^{The authors declare to have no fompeting interests related to this work.}

Introduction

The increasing prevalence of antibiotic resistance and the scarcity of therapeutic options for patients with penicillin allergy have highlighted the necessity for novel treatment regimens. Keverprazan, a novel potassium-competitive acid blocker, provides potent and sustained gastric acid suppression.

Aims & Methods

This study was designed to evaluate the efficacy and safety of keverprazan-minocycline (KM) dual therapy compared with keverprazan-amoxicillin (KA) dual therapy in patients with Helicobacter pylori (H. pylori) infection. From October 2024 to April 2025, a total of 240 patients with H. pylori infection were recruited from six hospitals in Fujian province and randomly assigned to receive either KA dual therapy (amoxicillin 1 g three times daily plus keverprazan 20 mg once daily) or KM dual therapy (minocycline 100 mg twice daily plus keverprazan 20 mg once daily) for a duration of 14 days. The primary endpoint was the H. pylori eradication rate assessed at 4 weeks post-treatment. Secondary endpoints included the symptom relief rate, incidence of adverse events, and patient compliance.

Results

In the intention-to-treat (ITT) analysis, the H. pylori eradication rates were 85.83% (103/120) in the KA group and 87.50% (105/120) in the KM group. In the per-protocol (PP) analysis, the eradication rates were 86.95% (100/115) in the KA group and 90.35% (102/113) in the KM group. No statistically significant differences were observed between the two groups (P = 0.704 for ITT and P = 0.421 for PP analysis). Additionally, symptom remission rates (73.88% vs. 82.50%) and treatment adherence rates (97.01% vs. 97.50%) also showed no significant intergroup differences (both P > 0.05). However, the KM group exhibited a significantly higher overall incidence of adverse events compared with the KA group (38.33% vs. 17.16%, P < 0.001), primarily driven by mild dizziness (25.83% vs. 2.23%, P < 0.001). However, these adverse reactions were mild and did not affect treatment adherence.

Conclusion

The keverprazan-minocycline dual regimen demonstrated high eradication efficacy and acceptable safety in patients with H. pylori infection, with eradication effectiveness comparable to that of the keverprazan-amoxicillin dual therapy and mild adverse reactions. This regimen is recommended for the clinical treatment of H. pylori infection, particularly in patients with penicillin allergy.

Disclosure

There is no conflict of interest.

Introduction

Due to certain shortcomings of traditional triple and quadruple therapy for Helicobacter pylori (H. pylori), high-dose dual therapy (HDDT) is proposed as another option.

Aims & Methods

Our study aims to evaluate the efficacy and safety of HDDT, and provide more reference for clinical eradication of H. pylori. The subjects were untreated H. pylori patients from three medical centers in Central China. Totally, 439 subjects were randomly assigned to EA (esomeprazole-amoxicillin) or B-quadruple (esomeprazole-amoxicillin-clarithromycin-bismuth) group. A total of 367 subjects were randomly assigned to VA (vonoprazan-amoxicillin) or VAC (vonoprazan-amoxicillin-clarithromycin) group. The effect, adverse events, compliance, symptom relief and cost were recorded.

Results

EA-dual was non-inferior to B-quadruple regimen in mITT and PP analysis (P<0.025). But the eradication rate of EA was lower than that of B-quadruple group (70.59% vs. 83.49%, 92.86% vs. 98.38%, 93.94% vs. 98.38%, ITT, mITT, PP respectively, P<0.05). In ITT, mITT and PP analysis, VA-dual was non-inferior to VAC treatment (84.15% vs. 83.15%, 96.25% vs. 92.73%, 96.75% vs. 93.75%, P<0.025). There was no significant difference in adverse events, compliance, and symptom relief between groups. Cost of VA was the lowest. Antibiotics use within 2 years, poor compliance and suburban area residence reduced the eradication efficacy (P<0.05).

Conclusion

The HDDT based on esomeprazole or vonoprazan was non-inferior to the classical B-quadruple or VAC triple regimen. So, the HDDTs should be recommended as first-line therapies of H. pylori eradication. Antibiotics use in 2 years, adherence and residence were crucial for eradication.

Disclosure

The authors declare that they have no conflict of interest.

Introduction

Minocycline is considered the most potent semi-synthetic tetracycline, demonstrates promising pharmacokinetic and antimicrobial properties against Helicobacter pylori (H. pylori). While previous studies suggested the efficacy of minocycline-containing bismuth quadruple therapy for H. pylori eradication, real-world evidence remains limited.

Aims & Methods

his study aimed to evaluate the clinical efficacy, safety, and cost-effectiveness of minocycline-containing bismuth quadruple therapy in routine clinical practice.This multicenter, real-world observational study was conducted at 25 hospitals in Fujian China between January and March 2025. Patients diagnosed with H. pylori infection received one of three 14-day bismuth-containing quadruple regimens with b.i.d. esomeprazole 20 mg and bismuth 220 mg, plus amoxicillin 1000 mg b.i.d. and clarithromycin 250 mg b.i.d. (PBAC), or minocycline 100 mg b.i.d. and clarithromycin 250 mg b.i.d. (PBMC), or minocycline 100 mg twice b.i.d. and levofloxacin 500mg q.d. (PBML). The primary outcome was the H. pylori eradication rate, secondary outcomes included the frequency of adverse events, patient compliance, and cost-effectiveness.

Results

A total of 347 patients were enrolled, with 110 patients completing treatment in each group. In the intention-to-treat (ITT) analysis, eradication rates were 77.4% (PBAC), 85.5% (PBMC), and 84.3% (PBML). In the per-protocol (PP) analysis, eradication rates were 80.9%, 90.9%, and 88.2%, respectively. Although the differences among the three regimens were not statistically significant, minocycline-based regimens achieved numerically higher eradication rates. Adverse event incidence was 32.73%, 20.91%, and 23.64% in the three groups, respectively. Compliance rates exceeded 94% across all groups. Cost-effectiveness analysis showed PBML had the lowest cost-effectiveness ratio (5.38 CNY per 1% eradication), followed by PBAC (5.41 CNY) and PBMC (6.06 CNY).

Conclusion

H. pylori eradication, with favorable patient compliance and pharmacoeconomic profiles. These regimens present a viable alternative to traditional amoxicillin-or tetracycline-based therapies. Further large-scale randomized controlled trials are warranted to confirm these findings.

Introduction

Potassium-competitive acid blockers (P-CABs) offer prolonged acid suppression and are promising agents for Helicobacter pylori eradication. Prospective studies evaluating the efficacy of tegoprazan-based triple therapy according to dosage differences have been scarce.

Aims & Methods

This study aimed to assess the efficacy and safety of tegoprazan-based versus lansoprazole-based standard triple therapy (STT). This multicenter randomized controlled study enrolled treatment-naïve adults with H. pylori infection in 18 institutions from February 2023 to April 2024. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC1), tegoprazan 100 mg (TAC2), or lansoprazole 30 mg (LAC) with amoxicillin 1000 mg and clarithromycin 500 mg twice daily for 14 days. The primary endpoint was the eradication rate, analyzed in the full analysis set (FAS) and per-protocol set (PPS). Secondary endpoints included eradication rates stratified by clarithromycin resistance, as determined by 23S rRNA genotyping. Non-inferiority was established if the lower bound of the 95% confidence interval (CI) for the difference in eradication rates was greater than -10%.

Results

A total of 382 patients were randomized, of whom 364 completed the study. The FAS included 372 participants after excluding those who did not receive any study medication, lacked safety data, or violated eligibility criteria. The PPS comprised 355 participants after excluding 17 protocol violators. In the FAS analysis, eradication rates were 85.95% for TAC1, 85.48% for TAC2, and 78.74% for LAC. Both TAC1 (p = 0.0002 vs. LAC) and TAC2 (p = 0.0003 vs. LAC) demonstrated non-inferiority. In the PPS analysis, eradication rates were 88.50% for TAC1, 87.39% for TAC2, and 81.30% for LAC, with TAC1 (p < 0.0001 vs. LAC) and TAC2 (p = 0.0003 vs. LAC) maintaining non-inferiority. Among 275 clarithromycin-susceptible patients in the PPS, eradication rates were 96.74% (TAC1), 98.88% (TAC2), and 94.68% (LAC). Among 80 clarithromycin-resistant patients, eradication rates were 52.38% (TAC1), 53.33% (TAC2), and 37.93% (LAC). In both subgroups, there were no significant differences between either TAC1 or TAC2 and the LAC group. Adverse event rates were comparable across groups, and no serious adverse events were reported. No significant differences in adverse event rates were observed across groups, and no serious adverse events occurred.

Conclusion

Tegoprazan-based STT demonstrated non-inferiority to lansoprazole-based STT, achieving eradication rates above 80% in the FAS population. Given its efficacy and safety profile, tegoprazan-based triple therapy may serve as an effective first-line treatment option for H. pylori eradication.

Disclosure

This study was funded in full by HK inno.N Corp., Seoul, Republic of Korea. HK inno.N Corp. contributed to the study design, data management, statistical analysis, and approval of publication in co-operation with all the authors. No other potential conflicts of interest relevant to this article were reported.

Introduction

It remains uncertain if the addition of Saccharomyces boulardii (S. boulardii) to Vonoprazan-amoxicillin dual therapy as a first-line treatment can enhance the Helicobacter pylori (H. pylori) eradication rate and decrease the incidence of adverse events. Therefore, we conducted the randomized controlled trials (RCTs) to address this issue.

Aims & Methods

This is a single-center, prospective randomized controlled study. A total of 150 eligible patients, recruited from December 2023 to November 2024, were randomly assigned to the VA (vonoprazan 20 mg twice daily, amoxicillin 750 mg 3 times daily for 10 days) and VAS groups (vonoprazan 20 mg twice daily, amoxicillin 750 mg 3 times daily, and S. boulardii 250 mg twice daily for 10 days). The eradication rates, adverse events, safety, and compliance were compared between the two groups. Factors associated with eradication rate were explored.

Results

The eradication rates of VA and VAS were 89.3% and 93.3%, respectively, by intention-to-treat analysis (P = 0.384); 93.1%, and 94.6%, respectively, by per-protocol analysis (P=0.966). The incidence of adverse events significantly lower in the VAS group (5.4%) than in the VA group (22.2%; P=0.003). There was no significant difference in compliance between the VA (96%) and VAS groups (98.7%, P = 0.612). Body surface area (BSA) was found to be a influencing factor for eradication rate in both VA and VAS groups. Serum chemistry tests revealed no significant differences in liver and kidney function before and after treatment in both groups.

Conclusion

Although the addition of S. boulardii to VA dual therapy could not increase the eradication rate, it could decrease the incidence of adverse events. Low-BSA patients are more suitable candidates for this regimen.