Actively Recruiting
Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication
Led by Asian Institute of Gastroenterology, India · Updated on 2025-06-11
484
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 rates irrespective of resistance patterns, has good compliance and minimal adverse events without the emergence of superbugs. We also need a reliable rescue therapy for H. pylori eradication failure.
CONDITIONS
Official Title
Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (18 years - 80 years)
- Patient visiting clinic with dyspepsia, GERD, or non-bleeding peptic ulcer
- Positive 13C-urea breath test or rapid urease test on endoscopic biopsy
- Off proton pump inhibitors for at least 2 weeks
You will not qualify if you...
- Allergy to penicillin
- Use of antibiotics within the past 1 month
- Previous treatment for H. pylori infection
- Presence of intestinal metaplasia, gastric cancer, or bleeding peptic ulcer
- Unable to understand study protocol or unwilling to consent
- Pregnancy or breastfeeding
- Use of anticoagulants or NSAIDs
- Use of drugs that interact with vonoprazan, amoxicillin, clarithromycin, or proton pump inhibitors
- Presence of cirrhosis, chronic kidney disease, or chronic lung disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AIG hospitals
Hyderabad, Telangana, India, 500082
Actively Recruiting
Research Team
K
Krithi Krishna Koduri Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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