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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
ChiCTR2100042739
Enrollment
Unknown
Registered
2021-01-27
Start date
2021-03-26
Completion date
Unknown
Last updated
2021-05-10

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

Conditions

Helicobacter pylori

Interventions

experimental group:VPZ 20 mg bid, Amoxicillin 1g bid, 14 days
2:Esomeprazole (20mg bid) + Amoxicillin (1g bid) + Clarithromycin (0.5g bid) + Livzon Dele (220mg bid), 14 days

Sponsors

Army Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18 to 70 years old, no gender limit; (2) Chronic gastritis diagnosed by gastroscopy, with or without healed gastric ulcer or duodenal ulcer; (3) Rapid urease test, urea breath test and Helicobacter pylori culture were all positive; (4) Have not received Helicobacter pylori eradication treatment in the past; (5) The patient or his legal representative signs an informed consent form, understands and agrees to follow the research requirements.

Exclusion criteria

Exclusion criteria: (1) PPI, potassium competitive acid blockers, antibiotics, H2 receptor antagonists, bismuth agents, probiotics and other drugs have been used within four weeks before treatment; (2) Pregnant or breast-feeding women, and patients with birth plans during the study period; (3) Take non-steroidal anti-inflammatory drugs, adrenal corticosteroids, anticoagulants, and alcoholism at the same time; (4) Patients who are allergic to the drugs used in this study; (5) There are other serious diseases that affect the evaluation of this study, such as severe liver disease, heart disease, kidney disease, malignant tumor, mental disease, etc.; (6) Patients who have had stomach and esophagus surgery before; (7) Participated in other drug researches within the first three months; (8) It is difficult to complete the follow-up or there are other factors that affect compliance; (9) Those who cannot sign informed consent.

Design outcomes

Primary

MeasureTime frame
Hp infection status;

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