13C-urea Breath Test Research Articles

Clinical and laboratory-instrumental characteristics of patients with dyspepsia syndrome not associated with <i>Нelicobacter pylori</i> infection

BACKGROUND: The significant prevalence of dyspepsia in patients without Нelicobacter pylori infection, difficulties in differential diagnosis necessitate the identification of the most common nosological variants, optimization of the diagnosis algorithm. AIM: To study clinical, laboratory and instrumental characteristics of patients with dyspepsia syndrome unrelated to Нelicobacter pylori infection. MATERIALS AND METHODS: A 13C-Urea Breath test was performed to 856 patients with uninvestigated dyspepsia. According to its results, 342 patients with Нelicobacter pylori infection were excluded from the study. The remaining patients (n = 514) with negative Нelicobacter pylori status underwent esophagogastroduodenoscopy and ultrasound examination of the abdominal organs. The patients with an identified organic pathology (n = 129) explaining dyspeptic complaints were excluded from the study. 208 out of the 385 patients without organic pathology agreed to undergo laboratory and instrumental examination in accordance with the study protocol. To assess dyspeptic complaints, 208 patients filled out a “Dyspepsia Questionnaire” developed by the authors. Demographic, anthropometric data, and complaints were recorded in all the study participants; experimental psychological testing was performed (Beck’s questionnaires, generalized anxiety disorder questionnaire-7, Short Form-36) and laboratory and instrumental examination (the level of pepsinogen I, pepsinogen II, immunoglobulin class G to Нelicobacter pylori and gastrin-17 in serum), esophagogastrogastroduodenoscopy with biopsy and pathomorphological assessment according to the Operative Link for Gastritis Assessment (OLGA) system, 24-hour esophageal impedance–pH monitoring, radiography of the esophagus and stomach. RESULTS: The majority of the patients with dyspepsia syndrome were not infected at the time of Нelicobacter pylori complaints — 514 (60.1%) patients. An in-depth examination of 208 people with a negative helicobacter status and the absence of an organic pathology explaining the symptoms revealed the heterogeneity of the final diagnoses. The results of the study demonstrate positive correlations between the level of depression, anxiety and the AET (acid exposure time) index, the number of acid reflux. A decrease in the level of pepsinogen I, gastrin-17, and the ratio of pepsinogen I/II was revealed with an increase in the degree and stage of atrophy according to the results of an Operative Link for Gastritis Assessment biopsy. CONCLUSIONS: The revealed variability of diagnoses and comorbidity in patients with similar complaints deepens the understanding of dyspepsia syndrome and explains the possible ineffectiveness of standard therapy regimens.

Association of Helicobacter pylori infection and white blood cell count: a cross-sectional study.

Helicobacter pylori is a type of Gram-negative microaerobic bacteria that inhabits the gastric mucosal epithelium. It can cause various gastrointestinal diseases including gastritis, peptic ulcer and gastric cancer. White blood cells (WBC) are common immune cells, the increase in whose countoften indicates the presence of an infection. Currently, the relationship between H. pylori and WBC count remains full of controversy. This study aims to further elucidate the effects of H. pylori on WBC count in a population undergoing physical examination. A total of 864 participants who underwent physical examination and 14C urea breath test (UBT) were retrospectively enrolled in this study from January to June 2021. The overall population was divided into H. pylori-negative (Hp-) and H. pylori-positive (Hp+) groups based on the disintegration per minute (DPM) value detected by UBT. Spearman's correlation analysis was used to assess the correlation between DPM and WBC count. General linear regression models were applied to assess the potential factors contributing to the increase in WBC count. Generalised additive model (GAM) was performed to identify the non-linear relationship between DPM and WBC count. Additionally, a piecewise linear regression was used to examine the threshold effect of the DPM on WBC count. 403 subjects were diagnosed with H. pylori infection. The WBC and platelet (PLT) counts in the Hp+ group were significantly higher than those in the Hp- group. Additionally, the prevalence of H. pylori infection gradually increased with the WBC count quartiles (38.89% and 54.67% in quartile 1 and quartile 4, respectively). Spearman's correlation analysis showed that the DPM value significantly correlated with WBC count (r=0.089, p=0.009) and PLT count (r=0.082, p=0.017). The linear model revealed a positive independent association of H. pylori infection and DPM with WBC count (βHp+=0.398 (95% CI 0.170, 0.625), p<0.001; βDPM=0.002 (95% CI 0.000, 0.0030), p=0.018). The results of the GAM and the piecewise linear regression suggested that the cut-off points of the association between DPM and WBC count were 40 and 155 of DPM, that is, the effect of DPM on WBC count varied with the difference of DPM <40, 40-155, and >155 (βDPM=-0.005 (95% CI -0.017, 0.007), p=0.423; βDPM=0.006 (95% CI 0.002, 0.013), p=0.047; and βDPM=-0.007 (95% CI -0.012, -0.002), p=0.004, respectively). H. pylori infection was independently and positively correlated with WBC count; however, the effect of DPM on WBC count varied across different WBC count intervals, suggesting distinct immunological responses at different stages of infection.

Efficacy of Bismuth Quadruple Therapy in the Treatment of Helicobacter pylori-Infected Peptic Ulcer Children in Vietnam.

The continuous increase in drug-resistant strains, the lack of novel antibiotics, and the fewer options available to combat antibiotic-resistant infections in pediatrics pose significant challenges to the eradication of Helicobacter pylori (H. pylori) in children. This study evaluated the efficacy of first-line therapy with bismuth quadruple therapy in H. pylori-positive pediatric patients with peptic ulcers. 136 patients (aged between 8 and 17 years) diagnosed with active peptic ulcers with H. pylori infection were enrolled in this study. Patients with H. pylori strain sensitive to tetracycline and metronidazole were assigned to bismuth quadruple therapy, including a proton pump inhibitor (PPI), bismuth, tetracycline, and metronidazole. Antibiotic resistance of H. pylori was analyzed by the Epsilometer test. Treatment efficacy was evaluated at 12 weeks based on H. pylori eradication and peptic ulcer healing rates. H. pylori infection status was evaluated by a 13C-urea breath test. Most isolates showed extremely high rates of resistance to commonly prescribed antibiotics used for children, including clarithromycin (97.0%) and amoxicillin (84.6%), while the low rate of resistance to levofloxacin (16.2%). The overall success rate of eradication therapy in the intention-to-treat and the per-protocol group were 86.0% and 89.3%, respectively. Peptic ulcer healing rates for total patients at 6 weeks and 12 weeks were 75.0% and 97.7%, respectively. There were no entail unpleasant adverse events, and peptic ulcer symptoms decreased steadily over time in all cases. The bismuth quadruple therapy with a 2-week PPI pretreatment and followed by prolonged PPI was highly successful in eradicating H. pylori infection and healing ulcers in pediatric patients with active peptic ulcer. This might be preferable as a first-line empiric treatment regimen for H. pylori-positive pediatric patients with peptic ulcers, especially in populations with high rates of resistance to amoxicillin and clarithromycin.

Helicobacter Pylori Infection Is not Associated with Nonalcoholic Fatty Liver Disease: A Two-year Cohort Study.

Previous studies reported inconsistent results of the association between Helicobacter pylori (H. pylori) infection and nonalcoholic fatty liver disease (NAFLD). A cohort study of 2063 adults without NAFLD at baseline, who participated in a repeated health check-up including a 13C urea breath test and abdominal ultrasonography, was conducted to evaluate the link between H. pylori infection and NAFLD development. During a mean follow-up period of 1.7 years, we did not found a significant association between H. pylori infection and NAFLD (Hazard ratio (HR) = 1.10 (0.86, 1.40), p = 0.4689). We also found that higher age, body mass index (BMI), systolic blood pressure (systolic BP), diastolic blood pressure (diastolic BP), fasting blood glucose, triglycerides, total cholesterol, low density lipoprotein cholesterol (LDL-C), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were risk factors, and high density lipoprotein cholesterol (HDL-C) was a protective factor for NAFLD development. H. pylori infection might not be positively related to NAFLD development.

Efficacy and safety of vonoprazan-based bismuth quadruple therapy for first-line Helicobacter pylori eradication: A large-scale, real-world study.

Vonoprazan (VPZ) has been shown to have superior acid-inhibitory effects compared to proton pump inhibitors (PPIs). However, there is a paucity of research examining the efficacy of vonoprazan-based bismuth quadruple therapy (VBQT) in the eradication of primary Helicobacter pylori infection. This study aimed to evaluate the effectiveness and safety of VBQT as a first-line treatment for H pylori eradication. This retrospective, real-world, single-arm study included consecutive treatment-naive patients who received VBQT (VPZ 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth potassium citrate 220 mg, all administered twice daily for 14 days) for H pylori eradication between March 1, 2021, and May 30, 2023. The study included both outpatients and inpatients. Eradication rates were assessed using 13C-urea breath tests or 14C-urea breath tests performed 4 to 6 weeks after treatment. The primary outcomes included eradication rates, adverse events, and treatment compliance. A total of 612 H pylori-infected patients were included in the study. The intention-to-treat (ITT), modified ITT (MITT), and per-protocol analyses showed H pylori eradication rates of 84.3% (95% CI: 812% to 87.1%), 95.9% (95% CI: 93.9% to 97.4%), and 96.4% (95% CI: 94.4% to 97.8%), respectively. In the ITT analysis, the adverse event rate was 12.7%, and the treatment compliance rate was 96.9%. In real-world practice, the VBQT regimen demonstrates excellent efficacy and favorable tolerability as a first-line therapy for H pylori eradication.

Association of long-term use of low-dose aspirin with Helicobacter pylori infection and effect on recurrence rate.

To investigate the relationship between long-term use of low-dose aspirin and Helicobacter pylori (HP) infection, and its effect on eradication and recurrence of HP. According to the results of C14-Urea Breath Test (C14-UBT), 3256 patients with cardiovascular and cerebrovascular diseases from March 2019 to December 2020, were divided into HP infection group and non-infection group. Univariate and multivariate was used to investigate the relationship between Low-dose aspirin use and HP infection. 859 patients with hypertension combined with HP infection were divided into aspirin group, non-aspirin group and control group, the eradication rate after 2 weeks of bismuth-containing quadruple drug treatment and the recurrence rate after 1,3 year were compared. The overall infection rate of HP was 53.3%. The results of univariate analysis showed that the infection rate of female, age, BMI, LDL-C, FBG of HP infected group was higher than non-infection. The infection rate of patients who took low-dose aspirin was higher than no-aspirin [56.6% vs. 51.3%, χ2 = 8.548, P = 0.003]. Multivariate Logistic regression analysis showed that long-term aspirin use still increased the risk of infection (OR = 1.433, 95% CI 1.196-1.947, P < 0.001). The Per-Protocol analysis showed that the overall eradication rate was 87.6%, and among the eradication rates of aspirin group, non-aspirin group and control group were not statistically significantly (87.8%, 88.5%, and 86.6%, respectively), The Intention-To-Treat analysis showed that the overall eradication rate was 84.3%, and the eradication rates among the three groups were not statistically significantly. The overall 1-year recurrence rate was 1.3%, and the recurrence rates of the three groups were no statistical significance. The overall 3-years recurrence rate was 3.1%, and the recurrence rate of aspirin group was higher than non-aspirin group and control group (5.30%, 1.90% and 1.70%, respectively, χ2 = 6.118, P < 0.05). The main adverse reactions in the first month of eradication treatment were constipation and mild nausea, and there was no statistical significance between the three groups. Long-term use of low-dose aspirin increases the risk of HP infection and the recurrence rate in 3 years after eradication. It is suggested that HP should be tested and eradicated regularly in long-term users.

Study on the clinical efficacy of 14-day vonoprazan-based triple regimen in obese patients with Helicobacter pylori infection

The effectiveness of vonoprazan (VPZ)-based regimens in enhancing Helicobacter pylori (HP) eradication rates is promising. This study evaluated the clinical efficacy of 14-day VPZ-based triple therapy in obese patients infected with HP. A total of 200 obese patients with gastric disorders, confirmed to be HP-positive via gastroscopy and the 13C urea breath test, were retrospectively analyzed. Among them, 118 patients received the 14-day VPZ-based triple regimen (Study group), while 82 patients were treated with the traditional 14-day bismuth-containing proton pump inhibitor-based quadruple regimen (Control group). Baseline characteristics, pretreatment inflammatory indicators, lipid profiles, and gastrointestinal function indicators recorded. The two groups were compared for treatment efficacy, HP eradication rate, gastrointestinal function improvement, and incidence of adverse reactions. The Study group demonstrated a higher overall effective rate compared to the Control group, particularly in HP-strong positive obese patients. No significant differences were observed between the two groups for HP-positive obese patients in terms of total effective rate, HP eradication rate, gastrointestinal function improvement, or adverse reactions incidence. In conclusion, the 14-day VPZ-based triple regimen exhibited superior therapeutic efficacy, higher HP eradication rates, enhanced gastrointestinal function, and reduced adverse reactions in HP-strong positive obese patients, indicating improved overall efficacy and safety.

Relationship between obesity severity and Helicobacter pylori eradication in patients undergoing bariatric and metabolic surgery: A post hoc analysis.

The global prevalence of obesity is increasing and represents a major public health challenge. However, there is a paucity of data regarding Helicobacter pylori (H pylori) eradication in people with obesity. The aim of the study is to examine the influence of obesity degree on H. pylori eradication in patients undergoing bariatric and metabolic surgery. A post hoc analysis was conducted in a cohort of 204 adults patients (129 individuals diagnosed with obesity, 75 normal weight) H. pylori positive, included in two multicenter, prospective studies. Patients underwent a 14-day quadruple concomitant treatment, and H. pylori eradication was assessed using the 13C-urea breath test. The cohort was stratified according to body mass index (BMI), and statistical analyses were performed using chi-squared test, Kruskal-Wallis test, and logistic regression. Eradication rates were significantly lower in patients with obesity compared with normal weight individuals (68.2% vs. 88.0%, OR 0.29, 95% CI 0.13-0.63, p < 0.01). Furthermore, within the population diagnosed with obesity, the degree of obesity correlated with decreased eradication rates, with class 3 (BMI 40.0-49.9) and class 4 (BMI ≥ 50.0) obesity showing the lowest rates (67% and 51%, with an OR 0.28 and 0.15 respectively, p < 0.01). Our results indicate that obesity may influence H. pylori eradication, especially among severe obesity patients undergoing bariatric surgery, which could have implications for the development of ulcers and gastritis as well as the risk of gastric cancer. Tailored eradication strategies may be necessary to improve treatment efficacy in this population.

Helicobacter pylori infection may result in poor gastric cleanliness in magnetically controlled capsule gastroscopy examination: A single-center retrospective study

ObjectiveMagnetically controlled capsule gastroscopy (MCCG) is an effective method for screening gastric diseases; however, its performance may be affected by gastric cleanliness. We aimed to explore the correlation between Helicobacter pylori infection and the degree of gastric cleanliness in the MCCG. MethodsThis retrospective study enrolled 297 participants from October 2020 to April 2024 at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. Participant characteristics, MCCG examination results, and (13) C-urea breath test (C13-UBT) results were collected. The gastric cleanliness in MCCG examinations was assessed using a gastric cleanliness score. Binary logistic regression was used to analyze the relationships among participant characteristics, H. pylori infection, and gastric cleanliness. Chi-square tests and Fisher's exact tests were used to analyze the relationships among gastric lesions, H. pylori infection, and gastric cleanliness. ResultsAmong the participants, 24.2% had H. pylori infection, and 17.5% had poor gastric cleanliness. Hypertension (odds ratio [OR]: 2.63; 95% confidence interval [CI]: 1.36–5.09; p = 0.004) was associated with a greater likelihood of H. pylori infection. H. pylori infection (OR: 3.76; 95% CI: 1.99–7.09; p < 0.001) was an independent risk factor for poor gastric cleanliness in the MCCG. A significant disparity was noted in the prevalence of focal erosions (p < 0.001), gastric ulcers (p = 0.001), and positive gastric lesions (p = 0.027) between the 2 groups with and without H. pylori infection. The proportion of positive gastric lesions was not significantly different between the good gastric cleanliness group and the poor gastric cleanliness group (25.7% vs. 21.2%; p = 0.490). ConclusionThe findings of this study revealed that H. pylori infection was associated with hypertension. H. pylori infection may lead to poor gastric cleanliness. Institutions are advised to perform C13-UBT before MCCG, and participants should be informed of the risk of poor gastric cleanliness if the results are positive. The decision to perform H. pylori eradication before MCCG should take into account patient willingness and the benefit-to-risk ratio.

Optimization of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Real-World Evidence Study.

The optimal dosage of minocycline remains unclear for Helicobacter pylori (H. pylori) eradication. We aimed to evaluate the efficacy and safety of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment. From March 2021 to March 2024, refractory H. pylori-infected patients with at least two previous treatment failures who received 14-day therapy with b.i.d. proton pump inhibitor 20 mg and bismuth 220 mg, plus tetracycline 400 mg q.i.d and metronidazole 400 mg q.i.d (BQT), or minocycline 50 mg q.i.d and metronidazole 400 mg q.i.d (PBMn4M4), or minocycline 50 mg t.i.d and metronidazole 400 mg t.i.d (PBMn3M3), or minocycline 50 mg b.i.d and metronidazole 400 mg q.i.d (PBMn2M4), or minocycline 50 mg b.i.d and metronidazole 400 mg t.i.d (PBMn2M3) were included in this retrospective study. H. pylori eradication was assessed by 13C-urea breath test at least 6 weeks after treatment. All adverse effects during treatment were recorded. Totally, 823 patients were enrolled: 251 with BQT, 97 with PBMn4M4, 191 with PBMn3M3, 108 with PBMn2M4, and 176 with PBMn2M3. The eradication rates of BQT, PBMn4M4, PBMn3M3, PBMn2M4, and PBMn2M3 were 89.2%, 87.6%, 91.6%, 88.0%, and 91.5%, respectively, by intention-to-treat analysis; 96.1%, 97.7%, 97.8%, 96.9%, and 97.6%, respectively, by modified intention-to-treat analysis; 97.1%, 97.5%, 97.7%, 96.8%, and 97.6%, respectively, by per-protocol analysis. Metronidazole resistance did not affect the efficacy of all groups. PBMn2M3 group achieved the greatest compliance and the fewest moderate and severe adverse events. The novel bismuth-containing quadruple therapy with a low dose of minocycline and metronidazole is an alternative to classical bismuth quadruple therapy for H. pylori rescue treatment with superior safety and compliance. ClinicalTrials.gov identifier: NCT06332599.

A randomised controlled clinical study of standard triple therapy, bismuth-based quadruple therapy and sequential therapy for Helicobacter pylori infection in children

Background and aimBismuth and non-bismuth quadruple therapy are the guideline-recommended first-line therapy in children with Helicobacter pylori infection in areas with high antibiotic resistance. However, their efficacy in children is uncertain and there are few well-designed studies. Here, we evaluated the eradication rates of standard triple therapy, bismuth-based quadruple therapy and sequential therapy in children with H. pylori infection.MethodsA randomised controlled trial was conducted in children infected with H. pylori in West China Second Hospital. They were randomly assigned to 14-day standard triple therapy (omeprazole + amoxicillin + clarithromycin), 14-day bismuth quadruple therapy (bismuth + omeprazole + amoxicillin + clarithromycin) and 10-day sequential therapy (omeprazole + amoxicillin for 5 days followed by omeprazole + clarithromycin + metronidazole for 5 days). The eradication rate was assessed by a 13C-urea breath test 4 to 6 weeks after therapy completion. Symptom improvement and adverse events were compared among the groups.ResultsIn total, 132 patients were enrolled. The eradication rates of 14-day standard triple therapy, 14-day bismuth quadruple therapy and 10-day sequential therapy were 70.0%, 78.9% and 50.0% in per-protocol analysis and 63.6%, 68.2% and 43.2% in intention-to-treat analysis, respectively. Symptom improvement and adverse drug event rates were similar in the three groups.ConclusionThe three therapeutic regimens evaluated in this study are equally not recommendable for H. pylori infection treatment due to unsatisfactory eradication rates. The high prevalence of clarithromycin resistance makes the use of clarithromycin-based quadruple therapy not advisable, even in combination with amoxicillin and bismuth salts.

Validity of rapid urease test using swab of gastric mucus to mucosal forceps and 13 C-urease breath test: a multicenter prospective observational study

BackgroundTheoretically, a rapid urease test (RUT) using a swab of the gastric wall (Swab-RUT) for Helicobacter pylori (H. pylori) is safe. However, the validity and utility of Swab-RUT remain unclear. Therefore, we assessed the validity and utility of Swab-RUT compared to RUT using mucosal forceps of the gastric wall (Forceps-RUT) and 13C-urea breath test (UBT).MethodsThis study was a multicenter prospective observational study. When the examinees were suspected of H. pylori infection during esophagogastroduodenoscopy, we performed Swab-RUT and Forceps-RUT continuously. When the examinees were not suspected of H. pylori infection, we performed Swab-RUT alone. We validated the status of H. pylori infection using UBT.ResultsNinety-four examinees were enrolled from four institutions between May 2016 and December 2020 (median age [range], 56.5 [26–88] years). In this study, the sensitivity, specificity, and accuracy of Swab-RUT to UBT were 0.933 (95% confidence interval: 0.779–0.992), 0.922 (0.827–0.974), and 0.926 (0.853–0.970), respectively. The Kappa coefficient of Swab-RUT to UBT was 0.833, and that of Swab-RUT to forceps-RUT was 0.936. No complications were observed in this study.ConclusionsSwab-RUT is a valid examination for the status of H. pylori infection compared to the conventional Forceps-RUT.

Data-driven rapid detection of Helicobacter pylori infection through machine learning with limited laboratory parameters in Chinese primary clinics

BackgroundHelicobacter pylori (H. pylori) is a significant global health concern, posing a high risk for gastric cancer. Conventional diagnostic and screening approaches are inaccessible, invasive, inaccurate, time-consuming, and expensive in primary clinics. ObjectiveThis study aims to apply machine learning (ML) models to detect H. pylori infection using limited laboratory parameters from routine blood tests and to investigate the association of these biomarkers with clinical outcomes in primary clinics. MethodsA retrospective analysis with three ML and five ensemble models was conducted on 1409 adults from Hubei Provincial Hospital of Traditional Chinese Medicine. evaluating twenty-three blood test parameters and using the C14 urea breath test as the gold standard for diagnosing H. pylori infection. ResultsIn our comparative study employing three different feature selection strategies, Random Forest (RF) model exhibited superior performance over other ML and ensemble models. Multiple evaluation metrics underscored the optimal performance of the RF model (ROC = 0.951, sensitivity = 0.882, specificity = 0.906, F1 = 0.906, accuracy = 0.894, PPV = 0.908, NPV = 0.880) without feature selection. Key biomarkers identified through importance ranking and shapley additive Explanations (SHAP) analysis using the RF model without feature selection include White Blood Cell Count (WBC), Mean Platelet Volume (MPV), Hemoglobin (Hb), Red Blood Cell Count (RBC), Platelet Crit (PCT), and Platelet Count (PLC). These biomarkers were found to be significantly associated with the presence of H. pylori infection, reflecting the immune response and inflammation levels. ConclusionAbnormalities in key biomarkers could prompt clinical workers to consider H. pylori infection. The RF model effectively identifies H. pylori infection using routine blood tests, offering potential for clinical application in primary clinics. This ML approach can enhance diagnosis and screening, reducing medical burdens and reliance on invasive diagnostics.

Radioactivity concentration of 14C in the air of 14C urea breath test rooms and the resulting internal dose to medical staff

ObjectiveTo monitor the radioactivity concentration of 14C in the air of rooms used to perform 14C urea breath tests, and evaluate the contamination status of 14C released during such tests, and assess the occupational health risk to medical staff working in such areas. Methods14CO2 in air was absorbed from the air and turned into calcium carbonate through a chemical reaction. Then, calcium carbonate was prepared into a suspension in a low-potassium glass vial. The sample was analyzed using a low-background liquid scintillation counter. ResultsThe radioactivity concentrations of 14C in air of the breath-test rooms in hospitals and physical examination institutions range from 1.35 to 18.41 Bq/m3. The annual committed dose for medical staff was estimated to be between 2.01 × 10−2 and 2.74 × 10−1 μSv. ConclusionsOur results reveal a significant increase of 14C radioactivity concentration in the air of breath-test rooms, but the resulting committed dose is much lower than the limits prescribed by the International Commission on Radiological Protection (ICRP). However, the potential risk of long-term exposure to low-dose radiation should be paid more attention.

Gastric cancer prevention by community eradication of Helicobacter pylori: a cluster-randomized controlled trial.

Gastric cancer is a leading cause of cancer-related deaths in China. Affecting more than 40% of the world's population, Helicobacter pylori is a major risk factor for gastric cancer. While previous clinical trials indicated that eradication of H. pylori could reduce gastric cancer risk, this remains to be shown using a population-based approach. We conducted a community-based, cluster-randomized, controlled, superiority intervention trial in Linqu County, China, with individuals who tested positive for H. pylori using a 13C-urea breath test randomly assigned to receiving either (1) a 10-day, quadruple anti-H. pylori treatment (comprising 20 mg of omeprazole, 750 mg of tetracycline, 400 mg of metronidazole and 300 mg of bismuth citrate) or (2) symptom alleviation treatment with a single daily dosage of omeprazole and bismuth citrate. H. pylori-negative individuals did not receive any treatment. We examined the incidence of gastric cancer as the primary outcome. A total of 180,284 eligible participants from 980 villages were enrolled over 11.8 years of follow-up, and a total of 1,035 cases of incident gastric cancer were documented. Individuals receiving anti-H. pylori therapy showed a modest reduction in gastric cancer incidence in intention-to-treat analyses (hazard ratio 0.86, 95% confidence interval 0.74-0.99), with a stronger effect observed for those having successful H. pylori eradication (hazard ratio 0.81, 95% confidence interval 0.69-0.96) than for those who failed treatment. Moderate adverse effects were reported in 1,345 participants during the 10-day treatment. We observed no severe intolerable adverse events during either treatment or follow-up. The findings suggest the potential for H. pylori mass screening and eradication as a public health policy for gastric cancer prevention. Chinese Clinical Trial Registry identifier: ChiCTR-TRC-10000979 .

Comparison of Four Tests for the Diagnosis of Helicobacter pylori Infection.

Due to lower operational costs, health maintenance organizations (HMOs) may prioritize Helicobacter pylori stool antigen testing (HpStAg) for the non-invasive diagnosis of H. pylori infection over 13C-urea breath tests (13C-UBTs). The aim of our study was to compare the accuracy of the diagnostic tests for H. pylori. We performed histology, rapid urease test (RUT), 13C-UBT and HpStAg on consecutive patients referred for gastroscopy. Monoclonal stool antigen test was performed using the LIAISON Meridian chemiluminescent immunoassay. Histology was examined with hematoxylin and eosin, and additional stains were performed at the pathologist's discretion. For the assessment of 13C-UBT, we compared concordant histology and RUT. HpStAg was compared to the concordant results of two of the three remaining tests. 103 patients were included (36 males (35.0%), age 50.1 ± 18.4 years). The indication for gastroscopy was dyspepsia in 63 (61.2%). Agreement between RUT and histology was 95.9%. For 13C-UBT and HpStAg, respectively, H. pylori positivity was 30% (30/100) and 27.16% (22/81); sensitivity was 97% and 70%; specificity was 100% and 94.4%; accuracy was 98% and 86%; positive predictive value (PPV) was 100% and 86.4%; negative predictive value (NPV) was 93% and 86%. No demographic, clinical, or endoscopic predictors of HpStAg accuracy were identified using logistic regression. 13C-UBT performs better than HpStAg at our institution. When interpreting results, clinicians should consider test limitations.

The impact of diet, exercise, and sleep on Helicobacter pylori infection with different occupations: a cross-sectional study

BackgroundAssociations between Helicobacter pylori infection and lifestyle factors vary greatly by geographic location. This study aims to evaluate the prevalence of Helicobacter pylori infection in the Hunan cohort of central China and analyze the associations between Helicobacter pylori infection and lifestyle factors in different occupations.MethodsThis was a cross-sectional study. Participants who received an annual physical examination were invited. Helicobacter pylori infection was detected by the 13 C-urea breath test. Self-reported physical examination questionnaires were used to analyze participants’ demographic information, diet, exercise status, and sleep situations.Results23254 participants finished this study. The Helicobacter pylori infection rate in the Hunan area was 25.8%, with the lowest prevalence in students (8.5%) and the highest prevalence in business managers (29.9%). The risk factors for Helicobacter pylori infection were marital status (divorced or married) (OR:1.16, 95%CI:1.090–1.234), overeating (OR:1.105, 95%CI: 1.001–1.220), and consumption of eggs (OR:1.047, 95%CI:1.004–1.092), animal viscera (OR: 1.077, 95%CI:1.014–1.144) and coffee (OR:1.074, 95%CI:1.019–1.132). Participants’ education level (OR:0.911, 95%CI:0.881-0942), consumption of midnight snack (OR:0.926, 95%CI:0.877–0.977), and vegetable (OR:0.927, 95%CI: 0.884–0.972) were protective factors against Helicobacter pylori infection. Whether participants exercised regularly or had sleep problems had no significant effect on Helicobacter pylori infection. Different professionals showed significant differences in the rates of overeating, eating three meals on time, midnight snack, and consuming coffee, eggs, animal viscera, and vegetables > 3 times/week (P values < 0.05).ConclusionsHelicobacter pylori infection showed a significant relationship with dietary factors, but not significantly with sleep and exercise factors. Different occupations showed different dietary tendencies related to Helicobacter pylori infection. The design of an occupation-based Helicobacter pylori screening and prevention program is supported.

Tetracycline Three Times Daily Versus Four Times Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Multicenter, Noninferiority, Randomized Controlled Trial.

Current guidelines recommend bismuth-containing quadruple therapy for patients newly diagnosed with Helicobacter pylori (H. pylori) infection. We aimed to compare the efficacy and safety of tetracycline administered three times daily versus four times daily in bismuth-containing quadruple therapy for first-line treatment of H. pylori infection. This multicenter, noninferiority, randomized controlled study, conducted in China, recruited treatment-naïve adults with H. pylori infection, randomized 1:1 into two treatment groups to receive either of the following bismuth-containing quadruple therapies: esomeprazole 20 mg twice-daily; bismuth 220 mg twice-daily; amoxicillin 1000 mg twice-daily; and tetracycline 500 mg three times daily (TET-T) versus 500 mg four times daily (TET-F). At least 6 weeks post-treatment, a 13C-urea breath test was performed to evaluate H. pylori eradication. In total, 406 patients were randomly assigned to the two treatment groups. Intention-to-treat eradication rates were 91.63% (186/203; 95% confidence interval [CI] 87.82%-95.44%) versus 90.15% (183/203; 95% CI 86.05%-94.25%) (p = 0.0005) and per-protocol eradication rates were 95.34% (184/193; 95% CI 92.36%-98.31%) versus 95.72% (179/187; 95% CI 92.82%-98.62%) (p = 0.0002) for the TET-T and TET-F group, respectively. TET-T-treated patients had a lower incidence of adverse effects than TET-F-treated patients (21.61% vs. 31.63%, p = 0.024), with no significant differences in compliance to treatment between the groups. As a first-line therapy for H. pylori infection, the eradication rate of the TET-T therapy was noninferior to that of the TET-F therapy while significantly reducing the incidence of adverse reactions. ClinicalTrials.gov identifier: NCT05431075.

Effects of fucoidan and synbiotics supplementation during bismuth quadruple therapy of Helicobacter pylori infection on gut microbial homeostasis: an open-label, randomized clinical trial.

The eradication regimen for Helicobacter pylori (H. pylori) infection can induce gut dysbiosis. In this open-label, prospective, and randomized clinical trial, we aimed to assess the effects of fucoidan supplementation on the eradication rate and gut microbial homeostasis in the context of quadruple therapy, as well as to investigate the combined effects of fucoidan and synbiotics supplementations. Eighty patients with H. pylori infection were enrolled and randomly assigned to one of four treatment groups: the QT (a 2-week quadruple therapy alone), QF (quadruple therapy plus a 6-week fucoidan supplementation), QS (quadruple therapy plus a 6-week synbiotics supplementation), and QFS (quadruple therapy with a 6-week fucoidan and synbiotics supplementation), with 20 patients in each group. The QT regimen included rabeprazole, minocycline, amoxicillin, and bismuth potassium citrate. The synbiotics supplementation contained three strains of Bifidobacterium, three strains of Lactobacillus, along with three types of dietary fiber. All of the patients underwent 13C-urea breath test (13C-UBT) at baseline and at the end of the 6th week after the initiation of the interventions. Fresh fecal samples were collected at baseline and at the end of the 6th week for gut microbiota analysis via 16S rRNA gene sequencing. The eradication rates among the four groups showed no significant difference. In the QT group, a significant reduction in α-diversity of gut microbiota diversity and a substantial shift in microbial composition were observed, particularly an increase in Escherichia-Shigella and a decrease in the abundance of genera from the Lachnospiraceae and Ruminococcaceae families. The Simpson index was significantly higher in the QF group than in the QT group. Neither the QS nor QFS groups exhibited significant changes in α-diversity or β-diversity. The QFS group was the only one that did not show a significant increase in the relative abundance of Escherichia-Shigella, and the relative abundance of Klebsiella significantly decreased in this group. The current study provided supporting evidence for the positive role of fucoidan and synbiotics supplementation in the gut microbiota. The combined use of fucoidan and synbioticss might be a promising adjuvant regimen to mitigate gut dysbiosis during H. pylori eradication therapy.

Real-world evidence of a novel tetravalent immunoglobulin Y effectiveness and safety in patients with the refractory Helicobacter pylori infection

BackgroundRefractory Helicobacter pylori (H. pylori) infection inevitably increase the difficulty of drug selection. Here, we described our experience with the use of a novel tetravalent IgY against H. pylori for the treatment of patients with refractory H. pylori infection.MethodsPatients were randomly assigned to receive the standard quadruple therapy (amoxicillin, clarithromycin, omeprazole and bismuth potassium citrate ) for 2 weeks or 250 mg of avian polyclonal IgY orally twice a day for 4 weeks. The binding efficacy of IgY to H. pylori antigens was detected by western blotting13. C-urea breath test was performed to evaluate the eradication therap’s efficacy. The side effects of IgY were evaluated via various routine tests. The questionnaire was used to gather clinical symptoms and adverse reactions.ResultsWestern blot analysis showed that tetravalent IgY simultaneously bind to VacA, HpaA, CagA and UreB of H. pylori. Tetravalent IgY had an eradication rate of 50.74% in patients with refractory H. pylori and an inhibition rate of 50.04% against DOB (delta over baseline) of 13C-urea. The symptom relief rate was 61.76% in thirty-four patients with clinical symptoms, and no adverse reactions were observed during tetravalent IgY treatment period.ConclusionsPolyclonal avian tetravalent IgY reduced H. pylori infection, and showed good efficacy and safety in the treatment of refractory H. pylori infection patients, which represented an effective therapeutic option of choice for patients with refractory H. pylori infection.