Comparing treatments for Helicobacter pylori eradication
Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication: A Single-center, Randomised, Controlled Trial.
This study is testing different treatment plans to see which one works best to get rid of Helicobacter pylori in adults who are having their first infection.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1404 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06168214 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of different treatment regimens for eradicating Helicobacter pylori in patients aged 18-70 with a first infection. Participants will receive either standard or short-course therapies involving Vonoprazan or Rabeprazole combined with antibiotics. The study will evaluate the primary outcome of eradication rates, as well as secondary outcomes including symptom relief and treatment compliance. The trial will assess various combinations of medications over different durations to determine the most effective approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with chronic gastritis, peptic ulcers, or dyspeptic symptoms and a confirmed Helicobacter pylori infection.
Not a fit: Patients who have contraindications to the study drugs, are pregnant or lactating, or have undergone upper gastrointestinal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and shorter treatment options for Helicobacter pylori infection.
How similar studies have performed: Other studies have shown varying success with different treatment regimens for Helicobacter pylori, but this specific comparison of Vonoprazan and Rabeprazole is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial. Exclusion Criteria: * Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.
Where this trial is running
Xi'an, Shaanxi
- Ying han — Xi'an, Shaanxi, China (Recruiting)
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.