Comparing two treatments for Helicobacter pylori infection
Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan
PHASE4 · Fu Jen Catholic University Hospital · NCT06156085
This study is testing a new treatment for Helicobacter pylori infection to see if it works better than the standard therapy for people over 20 who haven't been treated for it before.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Fu Jen Catholic University Hospital (other) |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT06156085 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a new vonoprazan-based dual therapy combined with high-dose amoxicillin against the standard extended sequential therapy for treating Helicobacter pylori infection. The study will recruit patients over 20 years old who have not previously undergone H. pylori eradication therapy. Participants will be randomly assigned to receive either treatment, and their outcomes will be compared to determine which regimen is more effective. The trial is being conducted at Fu Jen Catholic University Hospital in Taiwan.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 20 years old with a naive Helicobacter 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 provide a simpler and more effective treatment option for patients with Helicobacter pylori infection.
How similar studies have performed: While the vonoprazan-based dual therapy is a newer approach, similar studies have shown promising results with alternative regimens for H. pylori treatment.
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. Patient with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 mt2
Where this trial is running
New Taipei City
- Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Te-Ling Ma, MD
- Email: martin1985831@gmail.com
- Phone: 886905301798
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.
Conditions: Helicobacter Pylori Infection