H.Pylori Infection

In 2015, vonoprazan, a potassium-competitive blocker (P-CAB), was launched in Japan and used as an alternative for proton pump inhibitors (PPIs) for eradicating Helicobacter pylori. In recent studies, vonoprazan-based triple therapy significantly increased the eradication rate from 72.8% to 87.9%, compared to PPI treatment group. Accordingly, the Japanese Helicobacter treatment guidelines recommend prescribing P-CAB for eradication treatment. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for gastric ulcer treatment. Subsequently, it was proven effective in the treatment of reflux esophagitis compared to PPIs in a non-inferiority clinical trial. P-CAB can increase the gastric pH to 6 or higher within 7 hours after taking tegoprazan. Because tegoprazan can be taken after meals, it can improve patient compliance for H. pylori eradication. Unlike vonoprazan in Japan, however, tegoprazan-based eradication in Korean population was similar to conventional PPI-based treatment. To date, the eradication success rates of PPI and tegoprazan-based triple therapy were 76.4-84.2% and 77.3-84.3%, respectively, and there was no significant difference between the two treatment groups. Bismuth has long been used as a semi-metal in the dyspepsia and traveler's diarrhea. In H. pylori eradication therapy, several guidelines recommended the addition of bismuth to treatment regimens. Recently, bismuth was added to the 2-week triple regimen to increase the first-line H. pylori eradication rate in countries with high antibiotic resistance. The H. pylori eradication significantly increased from 87.5-88.1% to 95.8-97.3% in a recent study. The odds ratio was 1.63-2.18 in bismuth-added treatment group, compared to no use of bismuth group. In subgroup analysis, odd ratio was 1.66-2.22 in high clarithromycin-resistant areas. However, there was no comparative analysis of PPIs and tegoprazan in a bismuth-added triple therapy.

This study, titled CURE-H. Pylori, is a three-arm, parallel-group, open-label, randomized controlled trial designed to evaluate the effectiveness of Dexlansoprazole, Lansoprazole, and Vonoprazan in combination with Levofloxacin and Amoxicillin for Helicobacter pylori eradication. H. pylori infection is a significant health issue worldwide, with an estimated prevalence of 44% globally and around 60% in Pakistan, leading to gastritis, peptic ulcer disease, and increased risks of gastric cancer and mucosa-associated lymphoid tissue lymphoma. Despite the widespread use of PPI-based triple therapies, treatment efficacy has decreased due to increasing antibiotic resistance, especially to Clarithromycin and Metronidazole. This study aims to assess the eradication rate of H. pylori in patients receiving either Dexlansoprazole 60mg, Lansoprazole 30mg, or Vonoprazan 20mg, each combined with Levofloxacin 500mg and Amoxicillin 1g for 14 days. Participants will be randomized into three arms (314 participants per arm) and assessed for H. pylori eradication using a Urea Breath Test (UBT) at follow-up, which will serve as the primary endpoint. Secondary objectives include assessing symptom improvement using the Gastrointestinal Symptom Rating Scale (GSRS), measuring symptoms such as reflux, abdominal pain, indigestion, diarrhea, and constipation. The study will enroll adult patients diagnosed with H. pylori via UBT and who are not currently receiving treatment for the infection. The study will be conducted at healthcare centers in major cities across Pakistan, including Peshawar, Faisalabad, Rawalpindi, Multan, Lahore, Karachi, and Quetta, over a 12-month period. All participants will sign informed consent forms before enrollment, ensuring they understand the study's procedures and risks. Statistical analysis will be performed using SPSS version 26, with categorical variables analyzed using the Chi-square or Fisher's exact test and continuous variables using descriptive statistics. The primary outcome is the H. pylori eradication rate, and secondary outcomes include the improvement in gastrointestinal symptoms. This study is significant because it aims to compare three different PPI-based therapies in the context of H. pylori eradication in a high-resistance population, providing much-needed data for tailoring treatment strategies in regions with high antibiotic resistance like Pakistan. The results could enhance the effectiveness and cost-efficiency of treatment regimens for H. pylori, ultimately improving patient outcomes and reducing the burden of gastric diseases. Ethical approval has been obtained from the Institutional Review Board (IRB) of Dow University of Health Sciences, Karachi, and all procedures will adhere to the principles of human subjects protection. This study will provide valuable insights into the comparative efficacy of different proton pump inhibitors when combined with Levofloxacin-based triple therapy, potentially leading to more effective treatment options for H. pylori infections in Pakistan and similar regions. The total required sample size for this study is 942 participants, with a 20% expected dropout rate. Data collection will be conducted at baseline and six weeks post-treatment, with the aim of addressing the region-specific challenges in H. pylori treatment and contributing to the global knowledge on optimal therapeutic strategies for this infection. Additionally, the trial's findings may contribute to the broader understanding of how regional antibiotic resistance patterns affect treatment outcomes and help shape future guidelines for H. pylori management in endemic areas. This trial will also help assess the safety and tolerability of the different therapies, providing a comprehensive evaluation of both therapeutic efficacy and patient quality of life post-treatment.

This study aims to evaluate the knowledge, attitudes, and clinical practices of general practitioners regarding the diagnosis and treatment of Helicobacter pylori infection. The study also seeks to identify the main barriers that prevent proper management of the condition. The central hypothesis is that gaps in knowledge and challenges in clinical practice contribute to variations in how general practitioners diagnose and treat H. pylori infection.

It is a single-centre, prospective cohort study, which will be conducted in a tertiary academic hospital. The study aims to investigate intrafamilial H. pylori infection status and to identify risk factors for H. pylori infection among household members. The rate of intrafamilial H. pylori spread in Hong Kong is currently unknown. It is also not clear whether the same risk factors for intrafamilial spread of H. pylori infection also apply in Hong Kong. In contrast to mainland China and Taiwan , recent consensus guideline on H. pylori management in Hong Kong in 2023 recommends against routine testing of asymptomatic household members or family members of H. pylori-infected adults. There is a knowledge gap on whether the family-based H. pylori screening is cost effective in our locality. Thus, the investigator aim to investigate infection status of household members of H. pylori infected individuals and risk factors for household infection in Hong Kong. The result from this study will shed light on the role of family-based screening and can inform future healthcare policy making on the strategy of H. pylori management and treatment in Hong Kong, ameliorating H. pylori infection-related disease and gastric cancer burden for society.

The study is aimed to determine the potential of volatile marker testing for gastric cancer screening. The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.