Comparing different therapies for Helicobacter pylori eradication
Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H. Pylori Treatment
This study is testing three different treatment plans to see which one works best for adults with Helicobacter pylori infection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kaohsiung Medical University Academic / other |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT06349486 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the effectiveness and safety of three different treatment regimens for Helicobacter pylori infection: a 14-day bismuth-amoxicillin-vonoprazan triple therapy, a 14-day vonoprazan dual therapy, and a 14-day rabeprazole triple therapy. The study will recruit 780 adult patients from ten medical centers in Taiwan and will utilize a randomized, open-label design. Participants will be monitored for drug adherence and adverse events, with H. pylori status assessed through a breath test six weeks post-treatment. The trial will also explore the impact of antibiotic resistance and specific genetic factors on treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are infected with Helicobacter pylori.
Not a fit: Patients who have previously undergone treatment for Helicobacter pylori or have certain medical conditions, such as severe liver cirrhosis or malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide more effective treatment options for patients with Helicobacter pylori infection.
How similar studies have performed: Other studies have shown varying success with different treatment regimens for Helicobacter pylori, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (1) At least 18 years old. (2) Subjects infected with Helicobacter pylori. Exclusion Criteria: 1. Those who have ever received Helicobacter pylori sterilization treatment. 2. Those who are allergic to the drugs used in this research. 3. Those who have had stomach surgery. 4. Those with severe liver cirrhosis or uremia or malignant tumors. 5. Women who are pregnant or breastfeeding.
Where this trial is running
Kaohsiung City
- Kaohsiung Medical University Hospital — Kaohsiung City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Deng-Chyang Wu, MD, PHD
- Email: dechwu@yahoo.com
- Phone: 88673121101
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.