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Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

RecruitingPhase 4Ages 18 Years - 80 YearsAllAsian Institute of Gastroenterology, India
NCT06959368 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Helicobacter pylori (H Pylori) infection is associated with functional dyspepsia, peptic ulcer disease, atrophy and gastric cancer. The bacterium has been classified as grade I carcinogen by the WHO in 1994(1). Based on the clinical and microbiological data it is now well known to be the strongest risk factor for developing intestinal type and diffuse type of adenocarcinoma(2-4). While testing and treating asymptomatic persons is a grey area, it is now recommended to rule out H. pylori in un-investigated dyspepsia patients (5-7), and if detected, it must be treated. However, worldwide and especially in the Asian countries, we face a widespread problem of antibiotic resistance(8,9). Regimens are typically selected based on the varying regional clarithromycin resistance(6,9). There is a need for an efficient and reliable empirical therapy that can be universal, has maximal eradication rate

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult (18 years - 80 years) * Patient visiting clinic with dyspepsia, GERD, or non-bleeding peptic ulcer * 13C-urea breath test (UBT) positive/ Rapid urease test positive (RUT) on endoscopic biopsy * Off PPIs for 2 weeks Exclusion Criteria: * Penicillin allergy * Recent use of antibiotics in the past 1 month * Previous H. pylori therapy * Intestinal metaplasia, gastric cancer, bleeding peptic ulcer * Patient who is unable to understand study protocol or not consenting * Pregnancy, lactation * Patient on anticoagulation, NSAIDs * Patient using drugs with interactions with vonoprazan, amoxicillin, clarithromycin or PPIs * Cirrhosis, Chronic kidney disease, chronic lung disease
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What it tests

  • Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg
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Where

1 site
AIG hospitals
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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