Duco T Mülder, Yi-Chia Lee, Mario Dinis-Ribeiro, Melissa McLeod, Jin Young Park, Iris Lansdorp-Vogelaar
This article outlines how decision modeling can be used to optimize the cost-effectiveness of H. pylori screen-and-treat programs. Decision models enable the translation of data from pilot studies into locally tailored strategies by adapting test modalities, treatment options, and the need to retest specific to the local setting. We summarize existing evidence from modeling studies, which consistently demonstrate that H. pylori screen-and-treat is cost-effective across diverse populations. In addition, we discuss how decision modeling can support resource allocation, promote health equity, and guide implementation planning. Integrating H. pylori screen-and-treat into established preventive programs, such as colorectal cancer screening, may further increase efficiency and feasibility. The article concludes with a proposed research agenda to advance efficient H. pylori screen-and-treat programs across the globe.
{"title":"Optimizing Benefits-Harms of H. pylori Screen-and-Treat Programs Tailored to the Regional Settings.","authors":"Duco T Mülder, Yi-Chia Lee, Mario Dinis-Ribeiro, Melissa McLeod, Jin Young Park, Iris Lansdorp-Vogelaar","doi":"10.1111/hel.70111","DOIUrl":"10.1111/hel.70111","url":null,"abstract":"<p><p>This article outlines how decision modeling can be used to optimize the cost-effectiveness of H. pylori screen-and-treat programs. Decision models enable the translation of data from pilot studies into locally tailored strategies by adapting test modalities, treatment options, and the need to retest specific to the local setting. We summarize existing evidence from modeling studies, which consistently demonstrate that H. pylori screen-and-treat is cost-effective across diverse populations. In addition, we discuss how decision modeling can support resource allocation, promote health equity, and guide implementation planning. Integrating H. pylori screen-and-treat into established preventive programs, such as colorectal cancer screening, may further increase efficiency and feasibility. The article concludes with a proposed research agenda to advance efficient H. pylori screen-and-treat programs across the globe.</p>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"31 2","pages":"e70111"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12960071/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147354833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Martin O Sundqvist, Jonatan Wärme, Marcus Hjort, Per Tornvall, Tomas Jernberg, Bertil Lindahl, Alexandru Schiopu, Tomasz Baron, Stefan H Jacobson, Thomas Kahan, David Erlinge, Jonas Spaak, Robin Hofmann
Background: Helicobacter pylori (Hp) and its virulence factor Cytotoxin-associated gene A (CagA) have been linked to myocardial infarction (MI), but the mechanisms are unknown. This study aims to test if Hp infection and CagA are associated with pre-specified inflammatory and vascular biomarkers in patients with MI and to explore whether a broader biomarker panel can predict infection. Furthermore, it aims to investigate the association of Hp infection and biomarkers with major adverse cardiovascular events (MACE) and mortality.
Materials and methods: Hp, CagA serology, and 175 cardiovascular biomarkers were analyzed in 1061 patients with MI admitted between 2008 and 2014. Associations between Hp and seven pre-selected biomarkers were evaluated. Exploratory analyses included all biomarkers using machine-learning models to predict Hp-status. Hp-status and the top predictors were analyzed for associations with outcomes using Cox regression.
Results: Median age was 65 years; 78% were male. Hp and CagA seroprevalence were 45% and 19%, respectively. Patients with Hp had elevated CRP (β = 0.26, 95% CI 0.01-0.51). Predictive performance of Hp-status was moderate (AUC 0.63-0.68). Exploratory analysis identified higher levels of C-C motif chemokine ligand 20 (CCL20) and immunoglobulin heavy constant gamma-3 (IGHG3), and lower levels of TNF-related apoptosis-inducing ligand (TRAIL) in patients with Hp-positivity. Elevated CCL20 and reduced TRAIL, but not Hp, were associated with MACE and all-cause mortality.
Conclusions: Hp may contribute to an inflammatory response in patients with MI, indicated by higher CRP and inflammatory/immune-modulatory biomarkers emerging as its top predictors. Although Hp was not associated with adverse outcomes after MI, its predictive inflammatory biomarkers were associated with MACE and mortality.
Trial registration: The study was not registered as a clinical trial, as it was an observational study.
背景:幽门螺杆菌(Hp)及其毒力因子细胞毒素相关基因A (CagA)与心肌梗死(MI)有关,但其机制尚不清楚。本研究旨在测试Hp感染和CagA是否与心肌梗死患者预先指定的炎症和血管生物标志物相关,并探索更广泛的生物标志物是否可以预测感染。此外,该研究旨在调查Hp感染和生物标志物与主要不良心血管事件(MACE)和死亡率的关系。材料和方法:对2008年至2014年收治的1061例心肌梗死患者的Hp、CagA血清学和175项心血管生物标志物进行分析。评估了Hp与7种预先选择的生物标志物之间的关联。探索性分析包括使用机器学习模型预测hp状态的所有生物标志物。使用Cox回归分析hp状态和最高预测因子与结果的相关性。结果:中位年龄65岁;78%是男性。Hp和CagA血清阳性率分别为45%和19%。Hp患者CRP升高(β = 0.26, 95% CI 0.01-0.51)。hp状态的预测性能一般(AUC为0.63-0.68)。探索性分析发现,在hp阳性患者中,C-C基序趋化因子配体20 (CCL20)和免疫球蛋白重常量γ -3 (IGHG3)水平较高,tnf相关凋亡诱导配体(TRAIL)水平较低。CCL20升高和TRAIL降低与MACE和全因死亡率相关,但与Hp无关。结论:Hp可能促进心肌梗死患者的炎症反应,CRP升高和炎症/免疫调节生物标志物成为其主要预测因素。虽然Hp与心肌梗死后的不良结果无关,但其预测炎症生物标志物与MACE和死亡率相关。试验注册:该研究未注册为临床试验,因为它是一项观察性研究。
{"title":"Helicobacter pylori, Inflammation, and Long-Term Outcome in Patients With Acute Myocardial Infarction: A Prospective Cohort Study.","authors":"Martin O Sundqvist, Jonatan Wärme, Marcus Hjort, Per Tornvall, Tomas Jernberg, Bertil Lindahl, Alexandru Schiopu, Tomasz Baron, Stefan H Jacobson, Thomas Kahan, David Erlinge, Jonas Spaak, Robin Hofmann","doi":"10.1111/hel.70116","DOIUrl":"10.1111/hel.70116","url":null,"abstract":"<p><strong>Background: </strong>Helicobacter pylori (Hp) and its virulence factor Cytotoxin-associated gene A (CagA) have been linked to myocardial infarction (MI), but the mechanisms are unknown. This study aims to test if Hp infection and CagA are associated with pre-specified inflammatory and vascular biomarkers in patients with MI and to explore whether a broader biomarker panel can predict infection. Furthermore, it aims to investigate the association of Hp infection and biomarkers with major adverse cardiovascular events (MACE) and mortality.</p><p><strong>Materials and methods: </strong>Hp, CagA serology, and 175 cardiovascular biomarkers were analyzed in 1061 patients with MI admitted between 2008 and 2014. Associations between Hp and seven pre-selected biomarkers were evaluated. Exploratory analyses included all biomarkers using machine-learning models to predict Hp-status. Hp-status and the top predictors were analyzed for associations with outcomes using Cox regression.</p><p><strong>Results: </strong>Median age was 65 years; 78% were male. Hp and CagA seroprevalence were 45% and 19%, respectively. Patients with Hp had elevated CRP (β = 0.26, 95% CI 0.01-0.51). Predictive performance of Hp-status was moderate (AUC 0.63-0.68). Exploratory analysis identified higher levels of C-C motif chemokine ligand 20 (CCL20) and immunoglobulin heavy constant gamma-3 (IGHG3), and lower levels of TNF-related apoptosis-inducing ligand (TRAIL) in patients with Hp-positivity. Elevated CCL20 and reduced TRAIL, but not Hp, were associated with MACE and all-cause mortality.</p><p><strong>Conclusions: </strong>Hp may contribute to an inflammatory response in patients with MI, indicated by higher CRP and inflammatory/immune-modulatory biomarkers emerging as its top predictors. Although Hp was not associated with adverse outcomes after MI, its predictive inflammatory biomarkers were associated with MACE and mortality.</p><p><strong>Trial registration: </strong>The study was not registered as a clinical trial, as it was an observational study.</p>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"31 2","pages":"e70116"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12989639/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147463401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: To evaluate the associations of both baseline serological profiles and serological transitions of Helicobacter pylori infection patterns with the risk of precancerous gastric lesions (PGLs).
Design: We analyzed data from 6208 participants in the FuSion cohort who underwent gastroscopy examination, with available H. pylori antibody and pepsinogen measurements at both baseline and follow-up. H. pylori status defined by IgG antibodies (Ab) and pepsinogens (PG), classified participants into four ABC groups. Multivariable logistic regression evaluated associations with PGLs across baseline and transition statuses. Trend tests were performed across the ABC groups and infection transition categories.
Results: A significant increasing trend in the PGLs prevalence and severity was observed across the ABC groups (p for trend < 0.05). Analysis of infection transitions revealed graded risk increases for PGLs from consistently negative to remained positive groups. Interestingly, even participants who seroreverted remained at significantly elevated risks of atrophic gastritis (adjusted odds ratio [aOR] = 2.01, 95% CI: 1.67-2.43) and intestinal metaplasia (aOR = 1.72, 95% CI: 1.14-2.51) compared to the persistently negative participants. The sensitivity analyses excluding baseline PG-positive subjects yielded similar results.
Conclusion: Long-term exposure to H. pylori is associated with an increased risk of PGLs, and this risk may remain elevated even after seroreversion.
{"title":"Changes of Helicobacter pylori Infection Status and Risk of Precancerous Lesions: A Prospective Cohort Study in Chinese Population.","authors":"Xufei Xing, Renjia Zhao, Zixuan Cui, Qiaoyi Xu, Ziyu Yuan, Kelin Xu, Tiejun Zhang, Zhenqiu Liu, Yanfeng Jiang, Ming Lu, Weimin Ye, Chen Suo, Xingdong Chen","doi":"10.1111/hel.70114","DOIUrl":"10.1111/hel.70114","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the associations of both baseline serological profiles and serological transitions of Helicobacter pylori infection patterns with the risk of precancerous gastric lesions (PGLs).</p><p><strong>Design: </strong>We analyzed data from 6208 participants in the FuSion cohort who underwent gastroscopy examination, with available H. pylori antibody and pepsinogen measurements at both baseline and follow-up. H. pylori status defined by IgG antibodies (Ab) and pepsinogens (PG), classified participants into four ABC groups. Multivariable logistic regression evaluated associations with PGLs across baseline and transition statuses. Trend tests were performed across the ABC groups and infection transition categories.</p><p><strong>Results: </strong>A significant increasing trend in the PGLs prevalence and severity was observed across the ABC groups (p for trend < 0.05). Analysis of infection transitions revealed graded risk increases for PGLs from consistently negative to remained positive groups. Interestingly, even participants who seroreverted remained at significantly elevated risks of atrophic gastritis (adjusted odds ratio [aOR] = 2.01, 95% CI: 1.67-2.43) and intestinal metaplasia (aOR = 1.72, 95% CI: 1.14-2.51) compared to the persistently negative participants. The sensitivity analyses excluding baseline PG-positive subjects yielded similar results.</p><p><strong>Conclusion: </strong>Long-term exposure to H. pylori is associated with an increased risk of PGLs, and this risk may remain elevated even after seroreversion.</p>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"31 2","pages":"e70114"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147364877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zohar Levi, Naim Abu-Freha, Doron Boltin, Maya Aharoni Golan, Tom Konikoff, Orly Sneh Arbib, Rachel Gingold Belfer, Sapir Eizenstein, Alex Vilkin, Shiri Kusnir, Adi Turgeman, Tanya Babich, Moshe Leshno, Anath A Flugelman, Hadar Edelman-Klapper, Elizabeth Half-Onn
Background and aims: We evaluated the association between Fecal Immunochemical Test (FIT) results and the risk of gastroesophageal cancer (GEC) in a matched cohort, as well as the cost-effectiveness of a one-time esophagogastroduodenoscopy (EGD) for individuals who tested FIT-positive.
Methods: We formed a cohort of individuals aged 50-75 years who underwent FIT testing at Clalit Health in Israel from 2016 to 2019. For each person with a positive FIT result, we matched three individuals with negative results by age, gender, and H. pylori exposure. We used adjusted hazard ratios (adjHRs) to assess the association between a positive FIT result and the risk of GEC within 36 months. We calculated the incremental cost-effectiveness ratio (ICER) for a one-time EGD costing USD 350 in individuals who tested positive for FIT, and considered it cost-effective if below USD 50,000.
Results: The study included 150,391 individuals (47.6% female, median age 62.4 years). During follow-up, 202 cases of GEC were recorded: 0.17% in FIT-positive individuals (64/37,709) and 0.12% in FIT-negative individuals (138/112,682), adjHR 1.39 (95% CI 1.03-1.87). GEC was also associated with H. pylori exposure (adjHR 1.43, 95% CI 1.08-1.90) and immigration from high-risk countries. A one-time EGD demonstrated favorable cost-effectiveness across various scenarios, with an ICER of USD 25,535/QALY.
Conclusions: This matched-cohort study suggests that individuals with a positive FIT may have an increased risk of GEC, comparable to that of established high-risk populations. Adding a one-time EGD to colonoscopy for FIT-positive individuals may be a cost-effective approach for healthcare systems that can accommodate such interventions.
背景和目的:我们在一个匹配的队列中评估了粪便免疫化学试验(FIT)结果与胃食管癌(GEC)风险之间的关系,以及对FIT检测呈阳性的个体进行一次性食管胃十二指肠镜检查(EGD)的成本效益。方法:我们形成了一组年龄在50-75岁之间的个体,他们于2016年至2019年在以色列的Clalit Health进行了FIT测试。对于每个FIT结果呈阳性的人,我们根据年龄、性别和幽门螺杆菌暴露程度匹配了三个结果呈阴性的人。我们使用校正风险比(adjhr)来评估FIT阳性结果与36个月内GEC风险之间的关系。对于FIT检测呈阳性的个体,我们计算了一次性EGD费用为350美元的增量成本-效果比(ICER),如果低于5万美元,则认为其具有成本效益。结果:该研究纳入150,391例个体(47.6%为女性,中位年龄62.4岁)。随访期间,共记录202例GEC: fitt阳性者0.17% (64/37,709),fitt阴性者0.12% (138/112,682),adjHR 1.39 (95% CI 1.03-1.87)。GEC还与幽门螺杆菌暴露(adjHR 1.43, 95% CI 1.08-1.90)和来自高风险国家的移民有关。一次性EGD在各种情况下都具有良好的成本效益,ICER为25,535美元/QALY。结论:这项配对队列研究表明,FIT阳性的个体患GEC的风险可能增加,与已确定的高危人群相当。在fit阳性个体的结肠镜检查中增加一次性EGD,对于能够适应此类干预措施的卫生保健系统来说,可能是一种具有成本效益的方法。
{"title":"The Association of a Positive Fecal Immunochemical Test With the Risk of Gastroesophageal Cancer: An Age-Sex-H. Pylori Exposure Matched Cohort Study and Cost-Effectiveness Analysis.","authors":"Zohar Levi, Naim Abu-Freha, Doron Boltin, Maya Aharoni Golan, Tom Konikoff, Orly Sneh Arbib, Rachel Gingold Belfer, Sapir Eizenstein, Alex Vilkin, Shiri Kusnir, Adi Turgeman, Tanya Babich, Moshe Leshno, Anath A Flugelman, Hadar Edelman-Klapper, Elizabeth Half-Onn","doi":"10.1111/hel.70120","DOIUrl":"https://doi.org/10.1111/hel.70120","url":null,"abstract":"<p><strong>Background and aims: </strong>We evaluated the association between Fecal Immunochemical Test (FIT) results and the risk of gastroesophageal cancer (GEC) in a matched cohort, as well as the cost-effectiveness of a one-time esophagogastroduodenoscopy (EGD) for individuals who tested FIT-positive.</p><p><strong>Methods: </strong>We formed a cohort of individuals aged 50-75 years who underwent FIT testing at Clalit Health in Israel from 2016 to 2019. For each person with a positive FIT result, we matched three individuals with negative results by age, gender, and H. pylori exposure. We used adjusted hazard ratios (adjHRs) to assess the association between a positive FIT result and the risk of GEC within 36 months. We calculated the incremental cost-effectiveness ratio (ICER) for a one-time EGD costing USD 350 in individuals who tested positive for FIT, and considered it cost-effective if below USD 50,000.</p><p><strong>Results: </strong>The study included 150,391 individuals (47.6% female, median age 62.4 years). During follow-up, 202 cases of GEC were recorded: 0.17% in FIT-positive individuals (64/37,709) and 0.12% in FIT-negative individuals (138/112,682), adjHR 1.39 (95% CI 1.03-1.87). GEC was also associated with H. pylori exposure (adjHR 1.43, 95% CI 1.08-1.90) and immigration from high-risk countries. A one-time EGD demonstrated favorable cost-effectiveness across various scenarios, with an ICER of USD 25,535/QALY.</p><p><strong>Conclusions: </strong>This matched-cohort study suggests that individuals with a positive FIT may have an increased risk of GEC, comparable to that of established high-risk populations. Adding a one-time EGD to colonoscopy for FIT-positive individuals may be a cost-effective approach for healthcare systems that can accommodate such interventions.</p>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"31 2","pages":"e70120"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147503811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Vonoprazan (VPZ), a potassium-competitive acid blocker, has shown promising efficacy in Helicobacter pylori (H. pylori) eradication. However, direct comparisons of VPZ-based dual therapy (V-DT), triple therapy (V-TT), and bismuth quadruple therapy (V-BQT) remain limited. This study aimed to evaluate and compare the efficacy, safety, and compliance of these three regimens as first-line treatments for H. pylori infection.
Methods: 375 adults were randomized (1:1:1) to receive V-DT (VPZ 20 mg bid + amoxicillin 1 g tid for 10 days), V-TT (VPZ 20 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid for 14 days), or V-BQT (VPZ 20 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid + bismuth 240 mg bid for 10 days). The primary outcome was H. pylori eradication rate by intention-to-treat (ITT), modified ITT (mITT), and per-protocol (PP) analyses. Secondary outcomes included adverse events and compliance.
Results: Eradication rates were 92.0% (95% confidence interval [CI]: 85.8%-96.1%), 89.6% (95% CI: 82.9%-94.3%), and 88.8% (95% CI: 81.9%-93.7%) in ITT; 94.3% (95% CI: 88.5%-97.7%), 94.9% (95% CI: 89.3%-98.1%), and 94.1% (95% CI: 88.2%-97.6%) in mITT; and 94.2% (95% CI: 88.4%-97.6%), 95.6% (95% CI: 90.0%-98.5%), and 94.8% (95% CI: 89.0%-98.1%) in PP analyses for V-DT, V-TT, and V-BQT, respectively. The efficacy of V-DT and V-TT was noninferior to that of V-BQT. Adverse events were significantly lower with V-DT (6.4%) than with V-TT (36.0%) and V-BQT (49.6%) (p < 0.001). Compliance exceeded 93% in all groups, with no significant differences (p = 0.250).
Conclusions: All three regimens achieved high eradication rates, with V-DT and V-TT being statistically noninferior to V-BQT. The 10-day V-DT regimen achieved eradication rates comparable to V-BQT with substantially fewer adverse events and reduced antibiotic use, supporting its potential as a simplified first-line option for H. pylori eradication.
Trial registration: Chinese Clinical Trial Registration Number: ChiCTR2300072857.
{"title":"Efficacy and Safety of Vonoprazan-Based Dual, Triple, and Quadruple Therapies for Helicobacter pylori Eradication: A Randomized Controlled Trial.","authors":"Jin-Yan Zhang, Ji Li, Wei-Feng Huang, Xiao-Yi Lei, Yu-Lin Huang, Gui-Hua Xu, Dong Xu","doi":"10.1111/hel.70112","DOIUrl":"10.1111/hel.70112","url":null,"abstract":"<p><strong>Background: </strong>Vonoprazan (VPZ), a potassium-competitive acid blocker, has shown promising efficacy in Helicobacter pylori (H. pylori) eradication. However, direct comparisons of VPZ-based dual therapy (V-DT), triple therapy (V-TT), and bismuth quadruple therapy (V-BQT) remain limited. This study aimed to evaluate and compare the efficacy, safety, and compliance of these three regimens as first-line treatments for H. pylori infection.</p><p><strong>Methods: </strong>375 adults were randomized (1:1:1) to receive V-DT (VPZ 20 mg bid + amoxicillin 1 g tid for 10 days), V-TT (VPZ 20 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid for 14 days), or V-BQT (VPZ 20 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid + bismuth 240 mg bid for 10 days). The primary outcome was H. pylori eradication rate by intention-to-treat (ITT), modified ITT (mITT), and per-protocol (PP) analyses. Secondary outcomes included adverse events and compliance.</p><p><strong>Results: </strong>Eradication rates were 92.0% (95% confidence interval [CI]: 85.8%-96.1%), 89.6% (95% CI: 82.9%-94.3%), and 88.8% (95% CI: 81.9%-93.7%) in ITT; 94.3% (95% CI: 88.5%-97.7%), 94.9% (95% CI: 89.3%-98.1%), and 94.1% (95% CI: 88.2%-97.6%) in mITT; and 94.2% (95% CI: 88.4%-97.6%), 95.6% (95% CI: 90.0%-98.5%), and 94.8% (95% CI: 89.0%-98.1%) in PP analyses for V-DT, V-TT, and V-BQT, respectively. The efficacy of V-DT and V-TT was noninferior to that of V-BQT. Adverse events were significantly lower with V-DT (6.4%) than with V-TT (36.0%) and V-BQT (49.6%) (p < 0.001). Compliance exceeded 93% in all groups, with no significant differences (p = 0.250).</p><p><strong>Conclusions: </strong>All three regimens achieved high eradication rates, with V-DT and V-TT being statistically noninferior to V-BQT. The 10-day V-DT regimen achieved eradication rates comparable to V-BQT with substantially fewer adverse events and reduced antibiotic use, supporting its potential as a simplified first-line option for H. pylori eradication.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registration Number: ChiCTR2300072857.</p>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"31 2","pages":"e70112"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147354848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: The prevalence of Helicobacter pylori (H. pylori) infection in children is high. Current diagnostic methods, particularly invasive techniques like gastroscopy, pose challenges for pediatric populations, highlighting the need for reliable non-invasive alternatives.
Aims: This study aimed to evaluate the diagnostic value of salivary and urinary exosomes for detecting H. pylori infection and clarithromycin resistance in children.
Methods: Saliva and urine samples were collected from children prior to elective gastroscopy. Exosomal DNA was extracted and subjected to qPCR for the detection of H. pylori DNA and clarithromycin resistance. The sensitivity and specificity of the salivary and urinary exosome tests were calculated against the reference standard, and their performance in detecting resistance was compared with tissue-based results.
Results: Among 500 enrolled children, the H. pylori infection rate was 31.6%. Analysis of 500 salivary and 80 urine samples showed that salivary exosomes detected H. pylori with a sensitivity of 93.67% and specificity of 80.11%. Urinary exosomes offered higher specificity (90.56%) but lower sensitivity (62.96%). In the subset of 113 infected children tested for resistance, salivary exosome testing identified clarithromycin resistance in 17.70% of cases, showing a 91.15% concordance with gastric tissue testing (15.93%). The agreement between the two methods was substantial.
Conclusion: Salivary exosome-based detection represents a highly sensitive and well-tolerated non-invasive method for diagnosing H. pylori infection in children. It also demonstrates substantial agreement with invasive methods in identifying clarithromycin resistance, offering a promising tool to guide precise eradication therapy in the pediatric population.
{"title":"Exosome-Based Detection of Helicobacter pylori Infection and Clarithromycin Resistance in Children.","authors":"Minghui Song, Jingqing Zeng, Zhanyong Yao, Chundi Xu, Yiqiu Huang, Yuan Xiao, Yi Yu, Jia Li, Xu Xu, Chenchen Shi, Qiuchen Wu, Yonglin Tao, Xing Tang, Gloria Ge, Shenshen Gao, Zhaohui Deng, Xinqiong Wang","doi":"10.1111/hel.70113","DOIUrl":"10.1111/hel.70113","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of Helicobacter pylori (H. pylori) infection in children is high. Current diagnostic methods, particularly invasive techniques like gastroscopy, pose challenges for pediatric populations, highlighting the need for reliable non-invasive alternatives.</p><p><strong>Aims: </strong>This study aimed to evaluate the diagnostic value of salivary and urinary exosomes for detecting H. pylori infection and clarithromycin resistance in children.</p><p><strong>Methods: </strong>Saliva and urine samples were collected from children prior to elective gastroscopy. Exosomal DNA was extracted and subjected to qPCR for the detection of H. pylori DNA and clarithromycin resistance. The sensitivity and specificity of the salivary and urinary exosome tests were calculated against the reference standard, and their performance in detecting resistance was compared with tissue-based results.</p><p><strong>Results: </strong>Among 500 enrolled children, the H. pylori infection rate was 31.6%. Analysis of 500 salivary and 80 urine samples showed that salivary exosomes detected H. pylori with a sensitivity of 93.67% and specificity of 80.11%. Urinary exosomes offered higher specificity (90.56%) but lower sensitivity (62.96%). In the subset of 113 infected children tested for resistance, salivary exosome testing identified clarithromycin resistance in 17.70% of cases, showing a 91.15% concordance with gastric tissue testing (15.93%). The agreement between the two methods was substantial.</p><p><strong>Conclusion: </strong>Salivary exosome-based detection represents a highly sensitive and well-tolerated non-invasive method for diagnosing H. pylori infection in children. It also demonstrates substantial agreement with invasive methods in identifying clarithromycin resistance, offering a promising tool to guide precise eradication therapy in the pediatric population.</p>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"31 2","pages":"e70113"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147354868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Olga P. Nyssen, Guillermo J. Ortega, Laimas Jonaitis, Ángeles Pérez-Aísa, Bojan Tepes, Alfredo J. Lucendo, Javier Tejedor-Tejada, Renate Bumane, Ana Garre, Jose M. Huguet, Monica Perona, Óscar Núñez, Manuel Pabón-Carrasco, Manuel Castro-Fernández, Miguel Areia, Jesús Barrio, Antonio Moreno Loro, Thomas J. Butler, María Soledad Marcos, Alma Keco-Huerga, Manuel Domínguez Cajal, Maja Denkovski, Matteo Pavoni, György Miklós Buzás, Frode Lerang, Giuseppe Losurdo, Pablo M. Wolfe García, Perminder S. Phull, Samuel J. Martínez-Domínguez, Juozas Kupcinskas, Mārcis Leja, Ricardo Marcos-Pinto, Sinead M. Smith, Antonio Gasbarrini, Veronika Papp, Blas José Gómez Rodríguez, Mónica Sánchez Alonso, Ramón Pajares Villarroya, Pilar Pazo Mejide, Manuel Jiménez-Moreno, Marta Pascual-Mato, Concepción Bravo-Pache, Milagrosa Montes, Anna Cano-Català, Pablo Parra, Leticia Moreira, Francis Mégraud, Colm O’Morain, Luis Bujanda, Javier P. Gisbert, the Hp-EuReg investigators