Actively Recruiting
Comparison of Vonoprazan-based Versus Lansoprazole-based Triple Therapy, High Dose Dual Therapy, Bismuth and Non-bismuth Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection - a Multicenter, Open Labelled, Randomized Pilot Trial
Led by National Taiwan University Hospital · Updated on 2023-03-08
1200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness and safety of various vonoprazan-based and lansoprazole-based therapies for first-line treatment of Helicobacter pylori infection in adults aged 20 years and older. The trial investigates different drug combinations including dual, triple, quadruple, and reverse hybrid therapies, addressing the question of which regimen is superior or non-inferior, especially in areas with high clarithromycin resistance. It also explores long-term effects on gut microbiota, antibiotic resistance, TMAO levels, and metabolic parameters. Participants will be randomly assigned to one of eight treatment groups receiving either vonoprazan- or lansoprazole-based therapies with varying combinations and durations, ranging from 7 to 14 days. Those who do not achieve eradication after first-line therapy may receive further randomized treatment with vonoprazan-based levofloxacin triple or reverse hybrid therapies. The study includes detailed genetic and microbiological testing to understand resistance mechanisms and drug effects. Throughout the study, participants will undergo multiple assessments including stool and oral sample collections for microbiome sequencing at baseline, week 2, week 8, year 1, and year 2. Metabolic tests and a modified carnitine challenge test to assess TMAO production will also be conducted at these time points. The primary outcome focuses on eradication rate within 8 to 12 weeks, while secondary outcomes include treatment compliance, adverse events, and overall eradication after two treatments, with long-term follow-up for microbiome and metabolic changes.
CONDITIONS
Brief Title
Comparison of Vonoprazan-based Versus Lansoprazole-based Triple Therapy, High Dose Dual Therapy, Bismuth and Non-bismuth Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with naive H. pylori infection
- Subjects aged 20 years or older
You will not qualify if you...
- Younger than 20 years old
- Ever received H. pylori eradication therapy
- Ever received total or subtotal gastrectomy
- Severe chronic diseases such as end stage renal disease, liver cirrhosis, or incurable malignant tumors
- Women who are pregnant or breastfeeding
- History of allergies or serious side effects to study drugs
- Chronic hepatitis with AST or ALT greater than 40 IU/L
- Unable to sign informed consent by themselves
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 14 days
Participants receive one of several 7- to 14-day drug regimens aimed at eradicating H. pylori infection.
1 baseline visit and 1 follow-up visit within 8 to 12 weeks
Duration - Up to 2 years
Participants are monitored for eradication success, compliance, adverse events, and long-term changes in gut microbiota, antibiotic resistance, TMAO levels, and metabolic parameters.
Visits at week 2, week 8, year 1, and year 2
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
M
Mei-Jyh Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here