Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT06959368

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

AIG hospitals

Hyderabad, Telangana, India, 500082

Actively Recruiting

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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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