Condition: H. Pylori Gastrointestinal Disease · H.Pylori Infection · H.Pylori Eradication Rate · Sponsor: Dow University of Health Sciences
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 wi…
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| Sindh Institute of Advanced Endoscopy and Gastroenterology (SIAG), DUHS | Karachi, Pakistan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07344506