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Objective Helicobacter pylori is associated with gastric inflammation, precancerous gastric atrophy (GA) and intestinal metaplasia (IM). We aimed to identify microbes that are associated with progressive inflammation, GA and IM 1 year after H. pylori eradication.DesignA total of 587 H. pylori–positive patients were randomised to receive H. pylori eradication therapy (295 patients) or placebo (292 patients). Bacterial taxonomy was analysed on 404 gastric biopsy samples comprising 102 pairs before and after 1 year H. pylori eradication and 100 pairs before and after 1 year placebo by 16S rRNA sequencing.ResultsAnalysis of microbial sequences confirmed the eradication of H. pylori in treated group after 1 year. Principal component analysis revealed distinct microbial clusters reflected by increase in bacterial diversity (p<0.00001) after H. pylori eradication. While microbial interactions remained largely unchanged after placebo treatment, microbial co-occurrence was less in treated group. Acinetobacter lwoffii, Streptococcus anginosus and Ralstonia were enriched while Roseburia and Sphingomonas were depleted in patients with persistent inflammation 1 year after H. pylori eradication. A distinct cluster of oral bacteria comprising Peptostreptococcus, Streptococcus, Parvimonas, Prevotella, Rothia and Granulicatella were associated with emergence and persistence of GA and IM. Probiotic Faecalibacterium praustznii was depleted in subjects who developed GA following H. pylori eradication. Functional pathways including amino acid metabolism and inositol phosphate metabolism were enriched while folate biosynthesis and NOD-like receptor signalling decreased in atrophy/IM-associated gastric microbiota.ConclusionThis study identified that gastric microbes contribute to the progression of gastric carcinogenesis after H. pylori eradication.

ObjectiveThe objective of this study was to assess the efficacy, safety and tolerability of vonoprazan, a novel potassium-competitive acid blocker, as a component of Helicobacter pylori eradication therapy.DesignA randomised, double-blind, multicentre, parallel-group study was conducted to verify the non-inferiority of vonoprazan 20 mg to lansoprazole 30 mg as part of first-line triple therapy (with amoxicillin 750 mg and clarithromycin 200 or 400 mg) in H pylori-positive patients with gastric or duodenal ulcer history. The first 50 patients failing first-line therapy with good compliance also received second-line vonoprazan-based triple therapy (with amoxicillin 750 mg and metronidazole 250 mg) as an open-label treatment.ResultsOf the 650 subjects randomly allocated to either first-line triple therapy, 641 subjects completed first-line therapy and 50 subjects completed second-line therapy. The first-line eradication rate (primary end point) was 92.6% (95% CI 89.2% to 95.2%) with vonoprazan versus 75.9% (95% CI 70.9% to 80.5%) with lansoprazole, with the difference being 16.7% (95% CI 11.2% to 22.1%) in favour of vonoprazan, thus confirming the non-inferiority of vonoprazan (p<0.0001). The second-line eradication rate (secondary end point) was also high (98.0%; 95% CI 89.4% to 99.9%) in those who received second-line therapy (n=50). Both first-line triple therapies were well tolerated with no notable differences. Second-line triple therapy was also well tolerated.ConclusionVonoprazan is effective as part of first-line triple therapy and as part of second-line triple therapy in H pylori-positive patients with a history of gastric or duodenal ulcer.Trial registration numberNCT01505127.

ObjectiveSignificant heterogeneity was observed in previous trials that assessed the efficacies of sequential therapy for 10 days (S10) versus triple therapy for 14 days (T14) in the first-line treatment of Helicobacter pylori. We aimed to compare the efficacy of S10 and T14 and assess the factors affecting their efficacies.DesignWe conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects with H pylori infection naïve to treatment were randomised (1:1) to receive S10 (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, clarithromycin and metronidazole for another 5 days) or T14 (lansoprazole, amoxicillin and clarithromycin for 14 days). All drugs were given twice daily. Successful eradication was defined as negative 13C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test.ResultsThe eradication rates of S10 and T14 were 87.2% (567/650, 95% CI 84.4% to 89.6%) and 85.7% (557/650, 95% CI 82.8% to 88.2%) in the ITT analysis, respectively, and were 91.6% (556/607, 95% CI 89.1% to 93.4%) and 91.0% (548/602, 95% CI 88.5% to 93.1%) in the PP analysis, respectively. There were no differences in compliance or adverse effects. The eradication rates in strains susceptible and resistant to clarithromycin were 90.7% and 62.2%, respectively, for S10, and were 91.5% and 44.4%, respectively, for T14. The efficacy of T14, but not S10, was affected by CYP2C19 polymorphism.ConclusionsS10 was not superior to T14 in areas with low clarithromycin resistance.Trial registration numberNCT01607918.

The role of Helicobacter pylori (H. pylori) screening and eradication on reducing upper gastrointestinal bleeding (UGIB) complications after acute myocardial infarction (MI) is uncertain. The HELicobacter pylori screening to prevent gastrointestinal bleeding in patients with acute MI (HELP-MI SWEDEHEART) trial aims to determine whether systematic H. pylori screening compared to usual care reduces UGIB, mortality, and cardiovascular outcomes after MI. A cluster randomized, crossover, registry-based clinical trial using SWEDEHEART as trial platform for study population definition and source for data collection in combination with nationwide Swedish health data registries. Thirty-five Swedish hospitals, organized into 18 clusters based on percutaneous coronary intervention networks, were randomized to either routine H. pylori screening for adults with acute type-1 MI or usual care. After 1 year, a 2-month blanking period was followed by a crossover to the alternate allocation for 1 year. The trial enrolment was concluded after one additional year of registry-based follow-up. The primary endpoint is UGIB. Secondary endpoints include all-cause death, cardiovascular death, readmission for MI, stroke, or heart failure. Endpoints will be reported combined (Net Adverse Clinical Events; Major Adverse Cardiac or Cerebrovascular Events) and separately. The primary analysis will include all available follow-up time corresponding to a maximum follow-up time of 3 years and 2 months. HELP-MI SWEDEHEART aims to determine the utility of routine H. pylori screening to reduce UGIB and improve cardiovascular outcomes after MI. By integrating national registry follow-up data with a pragmatic trial design, it has the potential to provide evidence for the effect of the implementation of routine H. pylori screening as part of acute MI care. ClinicalTrials.gov, NCT05024864.

The primary objective of this study was to compare concomitant and hybrid therapy in the first line eradication treatment of Helicobacter pylori infection in Split-Dalmatia County, Croatia, in which clarithromycin resistance is above 20%. The secondary objective of the study was to determine and compare compliance and adverse events rate between these therapeutic protocols. In an open-label, randomised clinical trial 140 patients total with H. pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 g, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or hybrid (esomeprazole 40 mg and amoxicillin 1 g twice daily during 14 days with adding metronidazole 500 mg and clarithromycin 500 mg twice daily, in the last 7 days,) treatment group. Eradication rates for concomitant group and hybrid therapy group were 84.1% (58/69) and 83.1% (59/71) respectively in the intention-to-treat analysis and 96.7% (58/60) and 95.2% (59/62) in per-protocol analysis. There was no significant difference between the groups (ITT analysis: P = 0.878; PP analysis: P = 0.675). Adverse events were more frequent in the concomitant group (33.3% vs 18.3%, P = 0.043). There was no difference among groups regarding compliance rate. Hybrid therapy has similar eradication rate as concomitant therapy, with lower adverse events rate. In the era of increasing antibiotic resistance, eradication regime with less antibiotic's usage, as hybrid therapy, should be reasonable first line treatment choice for H. pylori infection. Clinical Trials, gov: NCT03572777.

IntroductionGastric cancer is a major global health concern, being the final stage of a long-term process, primarily associated with Helicobacter pylori (H. pylori) infection. Early childhood acquisition of H. pylori with low spontaneous eradication rates underscores the need for preventive measures. Our previous pilot treatment study revealed high eradication rates, favourable tolerance profile and a decline in serum biomarkers indicative of gastric damage in asymptomatic school-aged children. The purpose of this study is to determine the potential benefit of a ‘screen-and-treat’ strategy targeting persistently infected, asymptomatic adolescents. Specific aims are to assess eradication efficacy, its clinical and molecular outcomes and potential clinical and microbiological side effects.Methods and analysisThe screening phase will involve testing 500–1000 asymptomatic adolescents aged 14–18 from three cities in Chile using the urea breath test (UBT) to identify 210 participants with persistent infection. They will proceed to a randomised, non-blinded, controlled trial, receiving either a sequential eradication scheme for H. pylori or no treatment. Follow-up will span up to 24 months post-treatment, involving UBT, gastroenterological assessments and blood and stool sample collections. Concurrently, a subset of 60 uninfected adolescents will undergo matched follow-up. Enzyme-linked immunosorbent assay (ELISA) commercial kits will evaluate gastric damage biomarkers in serum (pepsinogen I and II, gastrin-17, VCAM-1, CXCL13). Stool samples will be employed for Escherichia coli and Enterococcus spp—culture, assessing AMR via the disk diffusion method. H. pylori clarithromycin resistance will be determined by molecular method from stool samples. The gut microbiome will be characterised by amplifying and sequencing the 16S rRNA gene from stool samples, followed by bioinformatics analysis.Ethics and disseminationApproved by the Human Research Ethics Committee at the Faculty of Medicine, University of Chile (073–2022). Findings will be disseminated in peer-reviewed journals and scientific meetings to guide future practices.Trial registration numberNCT05926804.

Studies conducted in large populations of patients and providing full information on Helicobacter pylori (H. pylori) antibiotic resistance are needed to determine the efficacy of sequential therapy (SQT) against this pathogen. This study compared eradication rates with SQT and standard triple therapy (STT), and evaluated the impact of antibiotic resistance on outcomes. The study population included adults with positive H. pylori culture presenting at four centers in China between March 2008 and December 2010. Patients were randomly assigned to 10 days of treatment with esomeprazole, amoxicillin, and clarithromycin (STT; n=140) or to 5 days of treatment with esomeprazole and amoxicillin, followed by 5 days of esomeprazole, clarithromycin, and tinidazole (SQT; n=140). Eradication was assessed 8-12 weeks after treatment. There was no significant difference between the eradication rates achieved with STT (66.4% (95% confidence interval (CI) 59.3-74.3)) and SQT (72.1% (65.0-79.3); P=0.300) in either the intention-to-treat analysis or the per-protocol analysis (72.7% (65.6-79.7) and 76.5% (69.7-83.3), respectively; P=0.475). Clarithromycin resistance (CLA-R, odds ratio (OR)=8.34 (3.13-22.26), P<0.001) and metronidazole resistance (MET-R, OR=7.14 (1.52-33.53), P=0.013) both independently predicted treatment failure in the SQT group. Patients in the SQT group with dual CLA-R and MET-R had a lower eradication rate (43.9%) than those with isolated CLA-R (88.9%, P=0.024) or isolated MET-R (87.8%, P<0.001). H. pylori eradication rates with STT and SQT were compromised by antibiotic resistance. SQT may be suitable in regions with high prevalence of isolated CLA-R, but it is unsatisfactory when both CLA-R and MET-R are present.

Background/Aims: Probiotics appear to improve Helicobacter pylori-associated dyspepsia via an inhibitory effect on H. pylori; however, uncertainty exists regarding their effects in H. pylori-uninfected individuals. We evaluated the efficacy of Lactobacillus gasseri OLL2716 (L. gasseri OLL2716) on H. pylori-uninfected individuals with functional dyspepsia (FD). Methods: A double-blind, parallel-group, placebo-controlled, randomized, controlled trial was performed. Participants were randomly assigned to ingest L. gasseri OLL2716-containing yogurt (L. gasseri OLL2716 group) or L. gasseri OLL2716-free yogurt (placebo group) for 12 weeks. Participants completed questionnaires that dealt with a global assessment as well as symptom severity. The per-protocol (PP) population was evaluated for efficacy in accordance with a plan prepared beforehand. Results: Randomization was performed on 116 individuals; the PP population consisted of 106 individuals (mean age 42.8 ± 9.0). The impressions regarding the overall effect on gastric symptoms were more positive in the L. gasseri OLL2716 group compared to that in the placebo group (statistical trend; p = 0.073). The elimination rate for major FD symptoms was 17.3 and 35.3% in the placebo and L. gasseri OLL2716 groups respectively (p = 0.048). Conclusion:L. gasseri OLL2716 has beneficial effects on FD without H. pylori involvement.

Some studies suggest that eradication of Helicobacter pylori (Hp) might increase the risk of gastroesophageal reflux disease (GERD) in a portion of patients. We aimed to conduct a meta-analysis to investigate this. A comprehensive, English, multiple-source literature search was performed from 1983 to February 2007. Only randomized controlled trial (RCT) and cohort studies comparing the prevalence of GERD in patients free from GERD at baseline with Hp eradication vs. those with persistent Hp were included. Quality of RCTs and cohorts was assessed by Jadad and New Castle-Ottawa scores, respectively. Meta-analysis of pooled odds ratios (ORs) was performed using Review Manager 4.2.10. Twelve (7 RCTs and 5 cohorts) of 271 articles were included. In six RCTs using erosive GERD as outcome, the OR for the frequency of GERD in Hp eradicated group vs. persistent Hp group was 1.11 (0.81-1.53, P=0.52). In five RCTs using symptomatic outcome, the OR for the frequency of GERD in Hp eradicated group vs. persistent Hp was 1.22 (0.89-1.69, P=0.22). In cohort studies, the OR for the frequency of GERD in Hp eradicated group vs. persistent Hp was 1.37 (0.89-2.12; P=0.15). Test of heterogeneity was not significant for any analyses. The results were consistent in subgroup and sensitivity analyses, including cohort studies vs. RCTs, high-quality studies vs. low-quality studies, and use of endoscopic vs. symptomatic outcomes except for the subgroup of patients with peptic ulcer disease (PUD) in cohort studies (OR: 2.04 (1.08-3.85); P=0.03). There is no association between Hp eradication and development of new cases of GERD in the population of dyspeptic patients. However, in cohort studies, there seems to be a twofold higher risk of development of erosive GERD in patients with PUD. The effect in RCTs of patients with PUD did not show a significant difference.

BackgroundAmoxicillin, metronidazole, proton pump inhibitor, bismuth quadruple therapy had been shown to reliably achieve high eradication rates. The role of individual components remains undefined.AimTo identify the additional benefit/role of bismuth in amoxicillin, metronidazole, proton pump inhibitor, bismuth quadruple therapy for Helicobacter pylori (H. pylori) treatment.MethodsThis was a non-inferiority factorial design trial. Treatment-naive H. pylori-infected subjects were randomly (1:1) assigned to receive 14-day amoxicillin- and metronidazole-containing triple therapy consisting of esomeprazole 20 mg twice a day, amoxicillin 1 g, and metronidazole 400 mg both thrice daily with or without 220 mg bismuth twice a day. Six weeks after treatment, H. pylori eradication was assessed by 13C-urea breath test. Antimicrobial susceptibility was assessed by the twofold agar dilution method.ResultsFrom July 2018 to June 2019, a total of two hundred and sixteen subjects were randomized. Both therapies achieved high eradication rates. Per-protocol with bismuth = 97.9% (94/96, 95% CI 95.1–100%) and without bismuth = 94.7% (90/95, 95% CI 90.3–99.1%) (P = 0.43). Intent-to-treat analysis = 90.7% (98/108, 95% CI 85.2–96.2%) versus 88.9% (96/108, 95% CI 82.8–95.0%) with and without bismuth (P = 0.65). The two regimens were not inferior by intent-to-treat or per-protocol analyses. Metronidazole resistance did not affect the efficacy of either therapy.ConclusionNeither the presence nor absence of bismuth or metronidazole resistance reduced the effectiveness of triple therapy containing esomeprazole 20 mg twice a day, amoxicillin 1 g, and metronidazole 400 mg thrice daily in this population. The clinical trial was registered with ClinicalTrials.gov, NCT03557437.