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A Randomized Controlled Study of Vonolasen Therapy and Bismuth-containing Quadruple Therapy in Patients with H.pylori Infection

A Randomized Controlled Study of Vonolasen Therapy and Bismuth-containing Quadruple Therapy in Patients with H.pylori Infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056375
Enrollment
Unknown
Registered
2022-02-04
Start date
2022-02-21
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

Helicobacter pylori infection

Interventions

Dual therapy:Vonolasheng-Amoxicillin: Vonolasheng 20mg bid, amoxicillin 1g tid, course of treatment for 14 days
Triple therapy:Vonolasheng-Amoxicillin-Clarithromycin: Vonolasheng 20mg bid, amoxicillin 1g bid, clarithromycin 0.5g bid, treatment course for 14 days
Quadruple Therapy:Esomeprazole-Tetracycline-Metronidazole-Bismuth Potassium Citrate: Esomeprazole 20mg bid, tetracycline 500mg tid, metronidazole 400mg tid, bismuth potassium citrate 0.6g (containing

Sponsors

The University of Hong Kong Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Over 18 years old and less than 75 years old; 2. From December 2021 to December 2022, patients aged 18-75 years who were confirmed to have Hp infection in the outpatient clinic of Shenzhen Hospital of the University of Hong Kong through a 13C urea breath test were the subjects of the study. Hp infection diagnosis method: 13C urea breath test (=4) positive can be judged as Hp infection;

Exclusion criteria

Exclusion criteria: Previous Hp eradication treatment, history of gastric surgery, pregnant women, lactating women, gastric malignant tumors or other serious systemic diseases, antibiotics, bismuth or other drugs that may affect Hp in the past 4 weeks (Including traditional Chinese medicine or probiotics), have used acid suppressants in the past 2 weeks, have used macrolide antibiotics repeatedly or for a long time, or are allergic to any of the drugs in the trial protocol, have used antiplatelet drugs such as aspirin or Anticoagulant drugs such as warfarin.

Design outcomes

Primary

MeasureTime frame
Negative or positive;

Secondary

MeasureTime frame
Symptom remission rate=(number of cases before treatment - number of cases after treatment)/number of cases before treatment × 100%;Drug compliance=Amount taken/amount prescribed * 100%;analysis of drug use cost;

Countries

China

Contacts

Public ContactLyu T ao

The University of Hong Kong Shenzhen Hospital

lvt@hku-szh.org+86 183 0755 6803

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026