Comparing different treatment durations for Helicobacter pylori eradication
Official title: Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial
Run by Shandong University · NCT06723197 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 330 (estimated) |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | December 10, 2024 |
| Main results expected | October 1, 2025 |
| Study ends | November 30, 2025 |
| Registry record updated | December 11, 2024 |
| Trial ID | NCT06723197 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown varying success with different treatment regimens for Helicobacter pylori, but this specific comparison of treatment durations is relatively novel.
Who can join: the full rules
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 it's running
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Qilu Hospital of Shandong University
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: Yanqing Li, Ph.D
- Email: liyanqing@sdu.edu.cn
- Phone: +8653188369277
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Dual vonoprazan and amoxicillin therapy for Helicobacter pylori infection in Uruguay
This trial tests whether a two-drug regimen (vonoprazan and amoxicillin for 14 days) can be as effective as the standard four-drug regimen for eradicating H. pylori in adults in Uruguay, with fewer side effects.
-
Dual-drug therapy with linlarase glutarate and amoxicillin vs bismuth quadruple therapy for first-line Helicobacter pylori eradication
This trial tests whether a dual-drug regimen of linlarase glutarate capsules plus amoxicillin can match the effectiveness of a standard bismuth-containing quadruple therapy for first-line Helicobacter pylori eradication.
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Feasibility of FFPE qPCR to Detect H. pylori and Clarithromycin Resistance
This study tests whether tissue samples already collected during gastroscopy can be used with qPCR to find Helicobacter pylori and its clarithromycin resistance.
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Adding bismuth to vonoprazan‑amoxicillin therapy for H. pylori
This study will test whether adding bismuth to a 14-day vonoprazan‑amoxicillin regimen improves H. pylori cure rates in adults who have never had eradication therapy.
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Endoscopic screening for H. pylori, intestinal metaplasia, and Barrett's mucosa during screening colonoscopy
This project will try adding a gastroscopy with biopsies to routine screening colonoscopy to see how often H. pylori and early stomach changes appear in adults without upper GI symptoms.
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Registry for managing Helicobacter pylori infection in Shandong Province
This registry will collect real-world information on H. pylori treatments given to adults in Shandong Province to see which approaches work best and are safest.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.