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A multi-center randomized controlled trial of Vonoprazan dual therapy and bismuth-containing quadruple therapy in newly treated patients with Helicobacter pylori

A multi-center randomized controlled trial of Vonoprazan dual therapy and bismuth-containing quadruple therapy in newly treated patients with Helicobacter pylori

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044092
Enrollment
Unknown
Registered
2021-03-10
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-07-21

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

Conditions

Helicobacter pylori

Interventions

The control group:Amoxicillin + metronidazole + esomeprazole + bismuth potassium citrate

Sponsors

Army Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18 ~ 70 years old, male or female; (2) chronic gastritis confirmed by gastroscopy, with or without healed gastric ulcer or duodenal bulb ulcer; (3) Both urea breath test and Helicobacter pylori culture were positive. (4) No previous H.pylori eradication therapy; (5) The patient or his legal representative signed the informed consent and understood and agreed to follow the study requirements.

Exclusion criteria

Exclusion criteria: (1) PPI, potassium competitive acid blockers, antibiotics, H2 receptor antagonists, bismuth agents, probiotics and other drugs were used within four weeks before treatment; (2) Pregnant or lactating women, patients who had a birth plan during the study period; (3) Simultaneous use of non-steroidal anti-inflammatory drugs, adrenocorticosteroids, anticoagulants and alcohol abuse during treatment; (4) Patients with allergies to the drugs used in this study; (5) Other serious diseases affecting the evaluation of this study, such as severe liver disease, heart disease, kidney disease, malignant tumor, mental disease, etc.; (6) Patients with previous gastric and esophageal surgery; (7) Participated in other drug studies within the previous three months; (8) It is difficult to complete follow-up or there are other factors affecting compliance.

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
Patient compliance;Symptoms of digestive tract were assessed before and after treatment;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactChun-Hui Lan

Army Medical Center

lanchunhui@tmmu.edu.cn+86 13896067955

Outcome results

None listed

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