CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Eradication

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.