13C-urea Breath Test Research Articles

The impact of Helicobacter pylori infection on low skeletal muscle mass risk in Chinese women over 40: a cross-sectional analysis.

Sarcopenia can lead to significant personal, social, and economic burdens. The diagnosis of sarcopenia heavily relies on the identification of Low Skeletal Muscle Mass (LSMM), which is an independent predictor of frailty, disability, and increased risk of death among seniors. Women have physiologically lower levels of skeletal muscle mass than men, and female sarcopenia appears to be more influenced by menopause. They also tend to have higher body fat levels than man, which increases the risk of sarcopenia obesity. On another front, it's also recognized that humans are largely prone to Helicobacter pylori (H. pylori) infection, with global prevalence rates often surpassing 50%. Nevertheless, the interconnection between H. pylori infection and LSMM remains relatively unexplored. Hence, our study specifically targeted women as the research population and sought to explore several risk factors for LSMM. Additionally, we delved into the potential correlation between LSMM and H. pylori infection in women, hoping to gain insights into potential preventative measures or treatment options that may enhance the quality of life for women affected by sarcopenia. We conducted a cross-sectional study among women aged over 18 years undergoing physical examination. We performed 13C-urea breath test (UBT) for diagnosis of H. pylori infection and Bioelectrical impedance analysis (BIA) for the assessment of LSMM. Logistic regression models were used to analyze the associations of H. pylori infection with LSMM. This study enrolled 1984 Chinese women who were undergoing health check-ups. A univariate logistic regression analysis did not reveal a direct correlation between H. pylori infection and LSMM among this female population (OR=1.149, 95% CI 0.904-1.459, p=0.257). Yet, upon dividing the participants into age-based subgroups, an evident link was observed between H. pylori infection and LSMM in women aged 40 or above (OR=1.381, 95%CI 1.032-1.848, p= 0.030). After adjusting for variables including Age, BMI, TP, ALK, Cre, this relationship remained statistically relevant (OR=1.514, 95%CI 1.085-2.113, p= 0.015). Women who are over 40 years old and currently infected with H. pylori have an increased risk of developing LSMM. Therefore, timely treatment for H. pylori eradication is recommended for this group of women to reduce the occurrence of LSMM.

Эпидемиология инфекции Helicobacter pylori в Российской Федерации с 1990 по 2023 г.: систематический обзор

H. pylori affects more than half of the world's population and is associated with chronic gastritis, which can progress to serious complications such as peptic ulcer disease, gastric cancer, and MALT lymphoma. Epidemiological studies allow for the assessment of the level and changes in the prevalence of H. pylori infection. This paper addresses the results of H. pylori prevalence studies conducted in the Russian Federation. The high prevalence of H. pylori in adults and children in the 1990s and its significant reduction in recent years are reported. The prevalence of infection in adults is greater than in children in all time intervals studied, which is probably associated with poorer sociohygienic conditions in childhood in previous generations. The results of epidemiological studies on the prevalence of H. pylori are heterogeneous and depend on the time of the study, the region, and diagnostic method. The prevalence of H. pylori infection as determined by the 13C urea breath test has been found to be lower than that observed in serological studies. This discrepancy is attributed to the greater specificity of the breath test in detecting current infection KEYWORDS: Helicobacter pylori, epidemiological study, prevalence of H. pylori, Helicobacter infection, Russian Federation. FOR CITATION: Bordin D.S., Kuznetsova E.S., Stauver E.E., Nikol'skaya K.A., Chebotareva M.V., Voynovan I.N., Neyasova N.A. Epidemiology of Helicobacter pylori infection in the Russian Federation from 1990 to 2023: a systematic review. Russian Medical Inquiry. 2024;8(5):260–267 (in Russ.). DOI: 10.32364/2587-6821-2024-8-5-3.

Initiation of a Helicobacter pylori Screening Program: Enhancing Healthcare at Juntendo University.

We started Helicobacter pylori (H. pylori) screening program of students at Juntendo university in 2020. We report the current status of H. pylori screening program and the outcomes of H. pylori screening program. The students of the School of the Faculty of Health Sciences of Juntendo University enrolling in the spring of 2020-2022 were recruited for this study. The anti-H. pylori antibody test was used for detecting H. pylori infection. An individual with a serum anti-H. pylori antibody titer of less than 3 U/ml was considered to be negative for H. pylori infection. If the antibody titer was 3 U/ml or higher, the subject was considered to be possibly infected and recommended to visit a hospital for further testing. Esophagogastroduodenoscopy and 13C urea breath test were performed for diagnosing H. pylori infection at the hospital. Eradication therapy was performed, and the eradication assessment were performed at least 8 weeks after the end of eradication therapy. Seven hundred twenty-eight students were screened for H. pylori from 2020 to 2022. Fifty-seven students were recommended to visit a hospital based on the anti-H. pylori antibody serum test. Forty-seven students visited Juntendo university hospital. Eleven of the 47 students were positive for H. pylori and all of them students received eradication therapy. H. pylori eradication was successful in nine of the 11 students. The H. pylori screening program for university students at Juntendo university has been successfully initiated with nine successful eradications since its inception in 2020.

Prevalence of Helicobacter pylori infection and risk factors among family members in Qinghai Province, China

Objective: To investigate the prevalence of Helicobacter pylori infection among family members, and analyze associated risk factors. Methods: The current investigation was a cross-sectional study. The Qinghai region was stratified into urban areas, agricultural areas, and pastoral areas. The urban areas of Xining City, the agricultural areas of Haidong City, and the pastoral areas of Haibei Tibetan Autonomous Prefecture were selected. A total of 396 resident families (1 131 people) who underwent health checkups from 2021 to 2022 in the above areas were included in the survey study. Questionnaires were administered and H. pylori infection was detected using the 13C-urea breath test. Numerical data were expressed as cases and percentages, and the Chi-square test was used to compare differences in H. pylori infection rates in the populations and families in each group. Multifactorial logistic regression was used to analyze risk factors for H. pylori infection, and P<0.05 was considered statistically significant. Results: The prevalence of H. pylori infection in Qinghai province was 52.8% (597/1 131) and the prevalence of H. pylori infection in households was 80.6% (319/396). In H. pylori-positive households with at least 1 infected spouse, 40.4% (36/89) had only 1 infected spouse, and in 59.6% (53/89) both spouses were infected. In analysis of children infected by parents with H. pylori, 20.0% (9/45) of households had fathers and children infected, 48.9% (22/45) had mothers and children infected, and 31.1% (14/45) had both parents and children infected. In univariate analysis there was a statistically significant difference in the overall comparison of H. pylori infection rates among families with different numbers of people living together (χ2=11.12, P=0.004), and between-group comparisons suggested that H. pylori infection rates were higher in families with 4 or 5 people and more than 5 people living together than in families with 2 or 3 people living together. The H. pylori infection rate was higher in families that did not use serving chopsticks and spoons during family meals than in families that did use serving chopsticks and spoons (χ2=6.12, P=0.013). In multifactorial logistic regression analyses the number of people living together in a family and whether or not serving chopsticks and spoons were used at family meals were associated with H. pylori infection (P<0.05). Conclusion: The H. pylori infection rate in families in Qinghai Province is high, and there is a clear association with family aggregation. It is more common for both members of a couple to be infected, and H. pylori infection of a mother has a greater effect on the children's infection status than H. pylori infection of a father. The infection rate of H. pylori was lower in families that used serving chopsticks and spoons during dinner gatherings, and the fewer the number of people living together in the family, the lower the H. pylori infection rate.

Vonoprazan and amoxicillin dual therapy for 14 days as the first-line treatment of Helicobacter pylori infection: A non-inferiority, randomized clinical trial.

We previously optimized the duration and dose of vonoprazan and amoxicillin dual therapy in China. The efficacy of vonoprazan with b.i.d. amoxicillin in comparison with vonoprazan-containing quadruple therapy as the first-line treatment of Helicobacter pylori infection has not been adequately evaluated. In a non-inferiority, randomized clinical trial, H. pylori infected and treatment-naïve patients were randomly assigned to receive 14 days of either vonoprazan dual (vonoprazan 20 mg and amoxicillin 1 g twice daily) or quadruple therapy (vonoprazan 20 mg + amoxicillin 1 g + furazolidone 100 mg + bismuth potassium citrate 600 mg twice daily). H. pylori status was confirmed using 13C-urea breath tests or fecal antigen test. The primary outcome was the H. pylori eradication rate following vonoprazan dual and quadruple therapy at 4-12 weeks. We also compared drug compliance to either regimen and documented their side effect. A total of 190 subjects were randomized. The eradication rate of vonoprazan dual and quadruple therapy were 87.4% and 92.6% (p = 0.23) by intention-to-treat analysis, respectively, and 96.5% and 97.7% (p = 0.63) by per-protocol analysis, respectively. The efficacy of vonoprazan dual therapy was non-inferior to vonoprazan-containing quadruple therapy in per-protocol analysis (p < 0.001; difference: -1.2%; 90% confidence interval: -5.4% to 3.0%). Vonoprazan with b.i.d. amoxicillin for 14 days provided similar satisfactory efficacy with vonoprazan-containing quadruple therapy as a first-line H. pylori treatment in China.

Gastric Helicobacter pylori infection does not contribute to extraoral halitosis and its eradication cannot achieve substantial reduction of halitosis

AbstractBackgroundSome researchers have suggested that Helicobacter pylori (H. pylori) infection is attributed to extraoral halitosis. However, this viewpoint is increasingly challenged by clinical practice. This study was conducted with the aim of investigating changes of extraoral halitosis before and after H. pylori eradication.Materials and MethodsData of patients who had H. pylori infection and extraoral halitosis were retrospectively collected. H. pylori infection was diagnosed by positive 13C urea breath test (UBT). Extraoral halitosis was diagnosed by organoleptic score (OLS) ≥2 in nose breath. A 14‐day bismuth‐based quadruple therapy was administered for H. pylori eradication. Extraoral halitosis was examined before eradication (T1), on the first day after eradication (T2), 1 month after eradication (T3), and 3 months after eradication (T4). Eradication effect was checked by UBT at T3.ResultsA total of 100 patients were included. Eradication was successful in 74 out of 100 (74%) patients (success group) and failed in 26 out of 100 (26%) patients (failure group). 32 out of 74 (43.24%) patients in success group and 10 out of 26 (38.46%) patients in failure group had reduced halitosis at T2, 9 out of 74 (12.16%) patients in success group and 2 out 26 (7.69%) patients in failure group had relapsed halitosis at T3, and 23 out of 74 (31.08%) patients in success group and 8 out of 26 (30.77%) patients in failure group had relapsed halitosis at T4, without significant difference between groups at any time (p = 0.918, p = 0.808, and p = 0.808 respectively).ConclusionsHelicobacter pylori infection does not contribute to extraoral halitosis. H. pylori eradication can achieve sustained but slight reduction of extraoral halitosis, probably due to its antibiotic effects on the gut microbiota rather than H. pylori.

Diagnostic Validity of a Serological Test with the Current Infection Marker in Thai Adults before and after Helicobacter pylori Eradication Therapy.

Helicobacter pylori infection poses significant health risks, such as gastric adenocarcinoma, necessitating accurate diagnosis and effective treatment in primary care. This study evaluated the diagnostic efficacy of the serological current infection marker (CIM) test in identifying current H. pylori infection. The CIM test samples from 159 participants undergoing gastroscopy were collected, and H. pylori-positive outpatients received triple therapy based on histology or rapid urease test results. Following treatment, 45 patients underwent a 13C-urea breath test and the CIM test for eradication assessment. For pre-eradication, the CIM test demonstrated 89.6% sensitivity, 95.7% specificity, 93.8% positive predictive value, 92.6% negative predictive value, and 93.1% accuracy. Following post-eradication, the CIM test exhibited sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 71.4%, 92.1%, 62.5%, 94.6%, and 88.9%, respectively, using the 13C-urea breath test as the reference standard. The CIM test showcased commendable diagnostic performance, emphasizing its efficacy in both pre- and post-eradication scenarios. Notably, the accuracy, non-invasiveness, user-friendliness, and cost-effectiveness of the CIM test advocate for its recommendation as a preferred diagnostic tool in primary care settings for H. pylori infection detection.

A population-based study of Helicobacter pylori: Does asymptomatic infection mean no gastroscopic lesions?

We determined the common clinical characteristics of patients infected with Helicobacter pylori (H. pylori) and investigated the relationship between H. pylori infection, and clinical symptoms, and gastroscopic manifestations. Our focus was specifically on the clinical manifestations in asymptomatic patients. We obtained the physical examination data of patients who underwent the 14C urea breath test between January 2018 and December 2020 at our Hospital. Basic demographic data, questionnaire data on clinical symptoms, and clinical examination data of the patients were also collected, and the correlation analysis was performed. A total of 2863 participants were included in the study. The overall H. pylori infection rate was 26.30%. The clinical symptoms between H. pylori-positive patients and H. pylori-negative patients did not differ significantly (P > .05). However, H. pylori-positive patients exhibited more severe gastroscopic manifestations (P < .001). The 14C urea breath test disintegrations per minute (DPM) values in H. pylori-positive patients correlated with their serum pepsinogen and gastrin-17 levels. With an increase in the DPM value, more combinations of clinical symptoms appeared in the patients. Among H. pylori-positive patients, DPM levels in asymptomatic patients were lower than those in symptomatic patients (P < .001). However, gastroscopic manifestations did not vary significantly between asymptomatic and symptomatic patients (P > .05). Patients infected with H. pylori showed no specific gastrointestinal symptoms. Patients with asymptomatic infection showed lower DPM levels, but their gastroscopic manifestations were similar to those of patients with symptomatic infection, and their lesions were more severe than H. pylori-negative people.

Helicobacter pylori Infection Status and Gastric Tumor Incidence According to the Year of Birth.

: The prevalence of Helicobacter pylori-naive status is increasing. Nonetheless, biennial gastroscopy is recommended for all Koreans aged 40 to 75 years. This study aimed to determine whether gastric cancer screening guidelines could be changed according to H. pylori infection status and year of birth. : Koreans who underwent serum assays and gastroscopy for gastric cancer screening between 2010 and 2016 were included if screening tests were followed up for ≥3 times. H. pylori infection was confirmed when invasive tests or 13C-urea breath tests were positive. In the case of negative test findings, eradication history, serologically detected atrophy, and intestinal metaplasia/atrophy were checked for past infection. If all were absent, H. pylori-naive status was confirmed. : Two-thousand and two (256 H. pylori-naive, 743 past-infected, and 1,003 infected) Koreans underwent screening tests for 95.5±28.4 months. The mean year of birth in the naive group (1969±7) differed from those of the past-infected (1957±10, p<0.001) and infected (1958±10, p<0.001) groups. H. pylori-naive status was correlated with recent year of birth (r=0.368, p<0.001). No gastric tumors were observed among the naive participants (p=0.007), whereas 23 adenomas, 18 adenocarcinomas, and two neuroendocrine tumors were detected in 1.9% (14/743) of past-infected and 2.5% (25/1,003) of infected participants, including four infected participants with metachronous tumors. : The prevalence of H. pylori-naive status is increasing in young Koreans, and gastric tumors are rare in this population. Hence, biennial gastroscopy could be waived after the confirmation of naive status.

Helicobacter pylori infection prevalence declined among an urban health check-up population in Chengdu, China: a longitudinal analysis of multiple cross-sectional studies.

The efficacy of updated health policy in improving the generalization of Helicobacter pylori screening and eradication in southwest China was assessed in a longitudinal analysis of multiple cross-sectional studies from an institution. In the periods 2009-2010, 2013-2014, and 2019-2021, 8,365, 16,914, and 18,281 urban observations from health check-ups at West China Hospital were analyzed, respectively. The 14C-urea or 13C-urea breath test was consistently used for H. pylori detection. The protocol has been reported elsewhere (PROSPERO Registration number: CRD42019120764). The overall prevalence of H. pylori dramatically decreased from 53.1% to 30.7% over the past decade (OR = 0.39, 95% CI 0.37-0.41), with a similar decline in all sex-specific and age-specific subgroups. The age-specific prevalence consistently increased before 40 years of age and always peaked at 50-59 years. Longitudinal clearance increased along with aging, and prevalence dropped to 22.6%, 25.1%, and 23.6% in the 40-49, 50-59, and 60-69 years initial age groups, respectively. The generalization of H. pylori screening and eradication could greatly contribute to the control of H. pylori infection among urban health check-up populations and lower gastric cancer incidence.

A Prospective Randomized Interventional Study to Establish the Role of Bovine Lactoferrin in Helicobacter Pylori Infection

Helicobacter pylori (H. pylori) are gram-negative spiral bacterium that surrounds itself in the epithelial surface of the stomach. It is found to be the most common bacterial infection affecting the population worldwide approximately 50%. The elimination of H. pylori is not only an important component in the healing of peptic ulcers, but also to decreases their recurrence and reduces the rate of gastric carcinoma. Eradication of H. pylori is currently recommended in numerous guidelines for the treatment of all these associated diseases. In the last two decades, attention has focused on the potential role of bovine lactoferrin (bLf) in the therapy of various gut disorders. bLf, a multifunctional iron-binding glycoprotein that is found in the milk, mucosal secretions (e.g., saliva, tears, bile), pancreatic and seminal fluids, and specific granules of the polymorphonuclear leukocytes in humans. Proton-pumpbased triple therapy (PpTT) is the most commonly accepted H. pylori treatment, which consists of a twice-daily proton pump inhibitor (PPI) such as esomeprazole or pantoprazole or omeprazole; clarithromycin or amoxicillin with tinidazole for 7-14 days. The aim of our study was to evaluate the efficacy of Bovine lactoferrin, administered orally along with triple therapy on H. pylori colonization in humans by a prospective randomized controlled study. 75 Patients with H. pylori positive were recruited and treated as per the protocol for 2 weeks. The subjects were randomized into 2 groups based on inclusion and exclusion criteria, interventional group received bovine lactoferrin at a dose of 100mg twice daily along with triple therapy for 14 days and the control group received, triple therapy for the same period of 14 days. The reduction in symptoms were analyzed by using a set of questionnaire and scored by using Global Overall Symptom Scale (GOS) both prior and post treatment. The eradication of H. pylori was confirmed by (13c) Urea breath test (UBT) that has shown the eradication rate of 76.2% in interventional group and 61.1% in control group. This study results had indicated that the group received bovine lactoferrin had shown significant improvement in the H. pylori eradication. This result can be used to conclude that the role of bovine lactoferrin in the reduction of symptoms and eradication of H. pylori infection by focusing on the relatively high cure rate, good compliance to the treatment and higher quality of life.

Association of serum vitamin D levels on Helicobacter pylori infection: a retrospective study with real-world data.

The aim of this study was to determine whether serum vitamin D levels are associated with H. pylori infection and whether low serum vitamin D levels are an independent risk factor for H. pylori infection. We conducted a retrospective analysis of a multicenter cohort study from 2017 to 2019. A total of 415 H. pylori+ patients and 257 H. pylori- patients aged between 18 and 75 years with both 13C-urea breath test and serum vitamin D level results were included from four hospitals. A questionnaire was used to collect information on potential factors influencing H. pylori infection. Serum vitamin D levels were significantly lower in the H. pylori+ group than in the H. pylori- group (16.7 ± 6.6 ng/ml vs. 19.2 ± 8.0 ng/ml, p < 0.05). Using a cutoff value of 20 ng/ml, the H. pylori infection rate was significantly higher in the vitamin D-deficient group (< 20 ng/ml) than in the vitamin D-nondeficiency group (≥ 20 ng/ml) (66.5% vs. 51.0%, p < 0.001). Ordered logistic regression analysis showed that serum vitamin D levels < 20 ng/ml (OR: 1.652, 95% CI: 1.160-2.351, p = 0.005), higher education levels (OR: 1.774, 95% CI: 1.483-2.119, p < 0.001), family size ≥ 4 (OR: 1.516, 95% CI: 1.081-2.123, p = 0.016), and lower annual income (OR: 1.508, 95% CI: 1.289-1.766, p < 0.001) were independent risk factors for H. pylori infection. Lower serum vitamin D levels may be associated with an increased risk of H. pylori infection, and lower serum vitamin D levels are an independent risk factor for increasing H. pylori infection rates. Randomized controlled trials are needed to determine whether supplementation with vitamin D can reduce H. pylori infection rates.

Room-Temperature NH3 Gas Surface Acoustic Wave (SAW) Sensors Based on Graphene/PPy Composite Films Decorated by Au Nanoparticles with ppb Detection Ability.

Exhaled human breath analysis has great potential for the diagnosis of diseases in non-invasive way. The 13C-Urea breath test for the diagnosis of Helicobacter pylori infection indicates the ammonia concentration of 50-400 ppb in the breath. This work successfully developed a surface acoustic wave (SAW) resonator based on graphene/polypyrrole composite films decorated by gold nanoparticles (AuNPs-G/PPy) with sensitivity and selectivity to detect ammonia in parts-per-billion concentrations, which is promising for the accurate diagnosis of H. pylori infection. XRD, EDS, and SEM characterized the AuNPs-G/PPy nanocomposites, providing comprehensive insights into their structural, compositional, and morphological properties. The gas-sensing capabilities of the fabricated SAW sensors were extensively investigated, focusing on their response to NH3 gas at ambient temperature. The concentration of ammonia gas was effectively quantified by monitoring the frequency shift of the SAW device. Notably, our developed SAW sensor demonstrated outstanding sensitivity, selectivity, repeatability, and reproducibility for 50-1000 ppb NH3 in dry air. The excellent sensing performance of the AuNPs-G/PPy hybrid composite film can be attributed to the synergistic effects of graphene's superior conductivity, the catalytic properties of gold nanoparticles, and the conductivity sensitization facilitated by electron-hole recombination on the polypyrrole surface.

Efficacy and safety of high-dose ilaprazole-amoxicillin dual therapy for Helicobacter pylori eradication: a prospective, single-center, randomized trial.

Background: Until now, there have been no randomized controlled trials directly evaluating the efficacy of high-dose ilaprazole-amoxicillin dual therapy (HT) in comparison to other standard treatments for H. pylori (Helicobacter pylori) infection. This study aimed to compare the effectiveness and safety of HT with bismuth quadruple therapy (BQT) as an initial treatment for H. pylori. Methods: This single-center, prospective, randomized clinical controlled trial recruited 225 consecutive patients. They were assigned to either HT group (ilaprazole, 10mg, twice daily; amoxicillin 1,000mg, three times daily) or BQT group (compound bismuth aluminate granules, 2.6 g, three times daily; ilaprazole, 5mg, twice daily; amoxicillin, 1,000mg, twice daily; clarithromycin, 500mg, twice daily) for 14days. The 13C-urea breath test assessed eradication success 4weeks after treatment. The primary outcome focused on the eradication rate, with secondary outcomes including safety and compliance. Results: From February 2023 to March 2023, 228 subjects were screened, and 225 were randomized. The HT and BQT groups showed eradication rates of 76.3% and 61.3% (p = 0.015) both by intention-to-treat (ITT) analysis and per-protocol (PP) analysis. HT was associated with fewer adverse events than BQT (27.2% vs. 81.8%, p = 0.002). The most commonly reported adverse events was bitter taste of mouth (3.5% vs. 60.4%, p < 0.001). There was no significant difference in compliance between the two groups (89.5% vs. 92.8%, p = 0.264). Conclusion: The 14-day HT treatment demonstrates better efficacy in H. pylori eradication treatment and improved safety and compliance compared to BQT. The results provide supporting evidence for 14-day HT can be potentially considered as a first-line regimen for empirical treatment. Clinical Trial Registration: https://www.chictr.org.cn/showproj.html?proj=186562, identifier ChiCTR2200066284.

Development of Isotopic Reference Materials for &lt;sup&gt;13&lt;/sup&gt;C-Urea Breath Tests

Over 30 standards and certified measurement techniques are currently used in Russia to determine carbon, oxygen, and hydrogen isotope ratios. The techniques implemented in these documents are based on foreign reference materials (RMs). Similar domestically-produced RMs are not available, which makes the use of these techniques limited in the near future. This study aims to develop a certified RM (CRM) for the isotopic composition of carbon dioxide for 13C-urea breath tests. The following objectives were formulated: to develop a technique for obtaining RMs; to manufacture an RM pilot batch; to carry out type approval tests. The RM was manufactured by gravimetric mixing of carbon dioxide of two different isotopic composition from different sources with synthetic air. The mixing ratio was calculated using a specially developed technique. The RM stability was tested by an accelerated aging procedure. Following type approval tests, the developed CRM was included in the Federal Information Fund for Ensuring the Uniformity of Measurements under the registration number GSO 11999–2022. The practical significance of the obtained results is related to the possibility of using the developed CRM for improving the accuracy and validity of 13C-urea breath tests. Compared to the analogs, the developed CRM demonstrates a higher chemical purity.

Efficacy and safety of Lacticaseibacillus rhamnosus R0011 and Lactobacillus helveticus R0052 as an adjuvant for Helicobacter pylori eradication: a double-blind, randomized, placebo-controlled study

BackgroundHelicobacter pylori eradication is recommended as a way of providing symptomatic relief for dyspepsia. The limited efficacy of triple therapy is a major problem in many countries, including Thailand. Some probiotics have been shown to improve the H. pylori eradication rate and reduce side effects. This study aimed at evaluating the efficacy of probiotic (Lacidofil® STRONG) as adjuvant to standard triple therapy.MethodsThis randomized, double-blind, placebo-controlled study was conducted between July 2020 and June 2022. Eligible patients with H. pylori gastritis (i.e., n=90 out of the 160 patients screened) were randomized to receive 14-day standard triple therapy either with probiotics or with a placebo (N=45/group). The treatment regimen entailed 30 mg lansoprazole administered twice daily, 1,000 mg amoxicillin administered twice daily, and 1 g clarithromycin modified-release formulation administered once daily. A probiotic capsule containing Lacticaseibacillus rhamnosus R0011 and Lactobacillus helveticus R0052 (Lacidofil® STRONG) or placebo were given twice daily during the eradication therapy and for an additional 4 weeks. Successful H. pylori eradication was defined as a negative 13C-urea breath test at least 4 weeks after complete eradication.ResultsAs per-protocol analysis, eradication rates after the 14-day regimen with probiotic or placebo were 90.9% and 75.0% (p=0.047), respectively. Antibiotic susceptibility testing demonstrated high clarithromycin resistance (24%). For clarithromycin-resistant strains, there was no statistical difference in eradication rates between the probiotic and placebo groups. Furthermore, probiotic supplementation significantly reduced treatment side effects, including bloating (OR 0.27 [95% CI 0.10 to 0.75], p=0.012), diarrhea (OR 0.23 [95% CI 0.28 to 0.65], p=0.006), nausea (OR 0.05 [95% CI 0.01 to 0.36], p=0.003), and bitter taste (OR 0.14 [95% CI 0.03 to 0.69], p=0.015). In addition, the probiotic group had lower gastrointestinal symptom rating scale (GSRS) scores (1.46 ± 0.36 vs. 2.65 ± 0.66, p&amp;lt;0.001) and higher SF-36 health-related quality-of-life scores (63.3 ± 10.2 vs. 57.3 ± 13.4, p=0.020) after treatment than the placebo group.ConclusionThe probiotic adjuvant with 14-day standard triple therapy improved the H. pylori eradication rate. Supplementation with Lacidofil® STRONG during the 2-week eradication treatment and 4-week follow-up phase can help to reduce the gastrointestinal side effects of eradication therapy and increase patients’ general health-related quality of life.

Correlation analysis of endoscopic manifestations and eradication effect of Helicobacter pylori.

Helicobacter pylori (H. pylori) infection is the most important risk factor for gastric cancer. Eradication of H. pylori significantly reduces the incidence and mortality of gastric cancer. H. pylori resistance to antibiotics and a gradual decline in eradication rates are gaining more and more attention. Our study aimed to address the correlation between endoscopic manifestations and the eradication effect of H. pylori. We retrospectively reviewed outpatients in our hospital with H. pylori infection undergoing eradication therapy from January 2022 to March 2023. Both the primary diagnosis and eradication of H. pylori after treatment were confirmed by a 13C urea breath test. Patients were treated with a proton pump inhibitor (PPI)-based quadruple therapy. Clinical characteristics and endoscopy manifestations within 7 days before or after patients were diagnosed with H. pylori infection were analyzed. From January 2022 to March 2023, a total of 323 patients were enrolled in this study. There were 138 male patients and 185 female patients. The mean age of patients was 45.62 ± 13.04 years. The H. pylori initial eradication rate was 82.0%. Univariate analysis of factors affecting H. pylori eradication showed that sex, age, and endoscopic manifestations including diffuse redness, multiple white, and flat elevated lesions, and atrophy were significantly associated with the failure of H. pylori eradication therapy. A multivariable logistic regression model analysis of these five factors showed that patients aged over 60 years with multiple white and flat elevated lesions in the endoscopic examination are significantly less likely to eradicate H. pylori with empirical quadruple therapy. On the other hand, patients with diffuse redness were significantly more likely to eradicate H. pylori infection with empirical quadruple therapy. Our study shows that age over 60 years old, multiple white and flat elevated lesions in endoscopic examination are independent risk factors of initial H. pylori eradication failure with empirical quadruple therapy, while diffuse redness in endoscopic examination is a protective factor of initial H. pylori eradication failure with empirical quadruple therapy, while diffuse redness in endoscopic examination is a protective factor. For patients with these risk factors, a drug sensitivity test or H. pylori resistance gene mutation detection may be more appropriate. However, further mechanism studies or prospective studies are needed to prove our findings.

Prospective Study of Vonoprazan-Based First-Line Triple Therapy with Amoxicillin and Metronidazole for Clarithromycin-Resistant Helicobacter pylori.

This was a prospective, multicenter, single-arm intervention, against historical controls, study of the efficacy of a vonoprazan-based 7-day triple regimen with metronidazole (VPZ-AMPC-MNZ) as a first-line therapy for eradicating clarithromycin-resistant Helicobacter pylori (H. pylori). We enrolled 35 patients positive for clarithromycin-resistant H. pylori, as assessed by culture, without a history of eradication. These 35 patients were prospectively eradicated with VPZ-AMPC-MNZ. As historical controls, we also assessed 98 patients with clarithromycin-resistant H. pylori from our prior prospective studies, who achieved H. pylori eradication with a 7-day triple regimen including clarithromycin (VPZ-AMPC-CAM). A preplanned analysis was performed as a superiority study against the historical controls (VPZ-AMPC-MNZ compared to VPZ-AMPC-CAM). In each regimen, vonoprazan was used at 20 mg bid, amoxicillin at 750 mg bid, metronidazole at 250 mg bid, and clarithromycin at 200 mg or 400 mg bid for 7 days. We assessed the outcome of eradication therapy using a 13C-urea breath test or H. pylori stool antigen test. We evaluated safety using patient questionnaires. The intention-to-treat (ITT) and per-protocol (PP) eradication rates of VPZ-AMPC-MNZ were both 100% (95% confidence interval (95% CI) 90.0-100%, n = 35). The eradication rates of VPZ-AMPC-CAM were 76.5% (95% CI 66.9-84.5%, n = 98) in the ITT analysis and 77.3% (95% CI 67.7-85.2%, n = 97) in the PP analysis. The eradication rate of VPZ-AMPC-MNZ was significantly higher than that of VPZ-AMPC-CAM in both the ITT (p = 0.00052) and PP (p = 0.00095) analyses. The findings suggest that 7-day VPZ-AMPC-MNZ was superior to 7-day VPZ-AMPC-CAM as a first-line regimen for eradicating clarithromycin-resistant H. pylori. We suggest VPZ-AMPC-MNZ as the standard first-line regimen for eradication of clarithromycin-resistant H. pylori in Japan.

A Vonoprazan, Clarithromycin, and Metronidazole Regimen as Helicobacter pylori Eradication Therapy for Patients with Penicillin Allergy in Light of Clarithromycin Resistance.

Objective Vonoprazan (VPZ), clarithromycin (CAM), metronidazole (MNZ) and VPZ, MNZ, and sitafloxacin (STFX) regimen are all established Helicobacter pylori eradication therapies for patients with penicillin allergy in Japan. However, no study has assessed the efficacy of a VPZ, CAM, and MNZ (VCM) regimen in patients with clarithromycin resistance (CAM-R). We therefore assessed the efficacy of a VCM regimen for treating H. pylori infection in patients with CAM-R and penicillin allergy. Methods Fifty-three patients with penicillin allergy who received H. pylori eradication therapy were retrospectively analyzed. Eight patients received a 7-day proton-pump inhibitor, CAM, and MNZ (PCM) regimen; 35 patients [11 CAM-R, and 10 with clarithromycin sensitivity (CAM-S)] received 7-day VCM regimens; and 10 patients received 7-day VPZ, MNZ, and STFX (VMS) regimens. A 13C-urea breath test was used to determine eradication. The efficacy of eradication was evaluated via both intention-to-treat (ITT) and per-protocol (PP) analyses. Results According to ITT and PP analyses, eradication rates (ERs) with PCM, VCM, and VMS therapies were 50.0% and 50.0%, 94.3% and 100%, and 90% and 90%, respectively. Treatment was successful in all patients with CAM-S. For patients with CAM-R, treatment was successful in 10 patients, and 1 patient discontinued treatment owing to an adverse event. According to ITT and PP analyses, ERs were 90.9% and 100% in CAM-R, and were 100% and 100% in CAM-S, respectively. Conclusion The VCM regimen for H. pylori eradication may be a viable candidate therapy for patients with penicillin allergy, regardless of CAM-R.

Efficacy and safety of vonoprazan-based dual therapy and esomeprazole-based dual therapy in eradicating primary Helicobacter pylori infection: A propensity score matching analysis.

According to the Maastricht VI/Florence consensus report, potassium-competitive acid blockers (P-CAB) may improve Helicobacter pylori eradication treatment. A total of 213 H. pylori treatment-naive patients aged between 18 and 70 years were treated with two regimens. The two regimens are VDT: 20 mg vonoprazan twice a day and 1 g amoxicillin three times daily and EDT: 20 mg esomeprazole four times a day and 750 mg amoxicillin four times daily. 13 C-urea breath tests were used to evaluate eradication rate 4-6 weeks after treatment. Based on propensity score matching (PSM), this retrospective study analyzed the eradication rates, adverse events (AEs), compliance, and antibiotic resistance rates in VDT and EDT groups. On intention-to-treat (ITT) analysis, the eradication rate in VDT group (89.0%; 95% CI 81.7-96.3) was non-inferior to that in EDT group (87.7%; 95% CI 80.1-95.3; p = 0.796). The corresponding per-protocol (PP) eradication rates were 94.1% (95% CI 88.4-99.8) and 92.8% (95% CI 86.7-98.9; p = 1.000), respectively. There were no significant between-group differences with respect to compliance or incidence of AEs. The efficacy and safety of 14-day VDT and EDT were comparable. Therefore, 14-day VDT or EDT may be recommended for the first-line treatment of H. pylori infection.