Comparing different treatment durations for Helicobacter pylori eradication
Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial
This study is testing how well different treatment lengths of two types of medications can get rid of Helicobacter pylori in people with the infection.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06723197 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of dual and quadruple treatment regimens for Helicobacter pylori eradication over varying durations of 7, 10, and 14 days. Participants will be randomly assigned to receive either a dual regimen of vonoprazan and amoxicillin or a quadruple regimen that includes vonoprazan, amoxicillin, tetracycline, and bismuth. The success of the treatment will be assessed using a 13C-urea breath test six weeks after completion of the regimen, with a focus on eradication rates, adverse reactions, and patient adherence.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 who have been diagnosed with a Helicobacter pylori infection and have not previously undergone treatment for it.
Not a fit: Patients with serious underlying health conditions, recent gastrointestinal surgery, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide more effective treatment options for patients suffering from Helicobacter pylori infections.
How similar studies have performed: Other studies have shown varying success with different treatment regimens for Helicobacter pylori, but this specific comparison of treatment durations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18-70 years old 2. Patients with H.pylori infection (13C/14C-urea breath test) 3. Patients without previous treatment for H. pylori eradication Exclusion Criteria: 1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75% 2. Patients with active gastrointestinal bleeding 3. Patients with a history of upper gastrointestinal surgery 4. Patients allergic to treatment drugs 5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks 6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial 7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse 8. Patients who are unwilling or incapable to provide informed consents
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Yanqing Li, Ph.D
- Email: liyanqing@sdu.edu.cn
- Phone: +8653188369277
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.