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Randomized Controlled Trial of Vonoprazan-Metronidazole-Bismuth Quadruple Therapy with Varying Durations for Helicobacter pylori Eradication: A Single-Center Study

Randomized Controlled Trial of Vonoprazan-Metronidazole-Bismuth Quadruple Therapy with Varying Durations for Helicobacter pylori Eradication: A Single-Center Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104165
Enrollment
Unknown
Registered
2025-06-12
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

Group A:Vonoprazan 20 mg twice daily (bid) , Amoxicillin 1.0 g twice daily (bid), Metronidazole 0.4 g three times daily (tid), Bismuth Potassium Citrate Capsules 0.6 g twice daily
treatment duration: 7 days.
Group B:Vonoprazan 20 mg twice daily (bid) , Amoxicillin 1.0 g twice daily (bid), Metronidazole 0.4 g three times daily (tid), Bismuth Potassium Citrate Capsules 0.6 g twice daily
treatment duration: 10days.
Group C:Vonoprazan 20 mg twice daily (bid) , Amoxicillin 1.0 g twice daily (bid), Metronidazole 0.4 g three times daily (tid), Bismuth Potassium Citrate Capsules 0.6 g twice daily
treatment duration: 14days.
Control Group:Esomeprazole Magnesium Enteric-Coated Capsules 20 mg twice daily (bid) + Amoxicillin 1.0 g twice daily (bid), Metronidazole 0.4 g three times daily (tid), Bismuth Potassium Citrate Capsu
treatment duration: 14 days.

Sponsors

The Fourth Central Hospital of Tianjin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Positive Hp infection confirmed by 13C or 14Cbreath test 2. Age 18-70 years; 3.Initial treatment of patients

Exclusion criteria

Exclusion criteria: 1. Those who have used antibiotics, bismuth agents,non-steroidal anti-inflammatory drugs or Chinese herbal medicines with antibacterial properties within one month; those who have used acid inhibitors within two weeks before HP eradication therapy; 2. Active peptic ulcer, accompanied by complications such as bleeding, perforation, obstruction and canceration; 3. History of esophageal or gastrectomy surgery; 4.Allergy to penicillin** or any other study medications. 5. Suffering from serious underlying diseases (heart, lungs, brain, liver, kidneys, etc.), suffering from malignant tumors or other diseases; 5. Pregnant or lactating women; 6. Participate in other research within three months and be unable to express one's own ideas correctly or cooperate with the researcher.

Design outcomes

Primary

MeasureTime frame
Eradication rate;

Secondary

MeasureTime frame
The incidence of adverse events;Economic benefit;

Countries

China

Contacts

Public ContactJing Zhang

The Fourth Central Hospital of Tianjin

286968105@qq.com+86 136 5217 1996

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026