Comparing different therapies for treating H. pylori infection
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
This study is testing different treatments for H. pylori infection to see which one works best for adults and how it affects their gut health and antibiotic resistance.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04713670 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of various treatment regimens for Helicobacter pylori infection, including vonoprazan-based dual and triple therapies, bismuth quadruple therapy, and lansoprazole-based therapies. A total of 1200 adult participants with confirmed H. pylori infection will be randomly assigned to receive one of the treatment regimens for 14 days. The study will also investigate long-term effects on gut microbiota, antibiotic resistance, and metabolic parameters following treatment. The goal is to determine which therapy is most effective in eradicating the infection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 years or older with a naive H. pylori infection.
Not a fit: Patients who have previously received H. pylori eradication therapy or have severe chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from H. pylori infection.
How similar studies have performed: Previous studies have shown that vonoprazan-based therapies can be superior to traditional treatments, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with naive H. pylori infection 2. Subjects with over 20 years old Exclusion Criteria: 1. Younger than 20 years old 2. Ever received H. eradication therapy 3. ever received total or subtotal gastrectomy in the past 4. Severe chronic disease, such as end stage renal disease, liver cirrhosis, incurable malignant tumors 5. Women who are pregnant or breastfeeding 6. Those who are not suitable to receive study drugs: such as a history of allergies to study drugs or serious side effects, etc. 7. Patients with chronic hepatitis (AST or ALT \>40 IU/L) 8. Subjects who cannot sign informed consent by themselves
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Jyh-Ming Liou, MD — National Taiwan University Hospital
- Study coordinator: Mei-Jyh Chen, MD
- Email: migichen@ntuh.gov.tw
- Phone: 88623123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.