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Vonoprazan-containing triple therapy versus empiric bismuth quadruple therapy for first-line Helicobacter pylori treatment: a Randomized Clinical Trial

Vonoprazan-containing triple therapy versus empiric bismuth quadruple therapy for first-line Helicobacter pylori treatment: a Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068057
Enrollment
Unknown
Registered
2023-02-06
Start date
2023-02-06
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Helicobacter pylori infection

Interventions

Vonoprazan-containing triple therapy test group:Vonoprazan 20mg bid, Amoxicillin 1000mg tid, Metronidazole 400mg tid
empiric bismuth quadruple therapy control group:Esomeprazole 20mg bid. Bismuth 220mg bid. Amoxicillin 1000mg tid. Metronidazole 400mg tid

Sponsors

Shanghai East Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18-70 years; 2. Patients diagnosed as Hp positive by gastroscopy with a positive rapid urease test, who have never received previous HP eradication treatment; 3. Patients with gastroscopically confirmed gastritis or inactive peptic ulcer; 4. Those who have not used antibiotics, bismuth, H2RA, PPI, P-CAB, etc. for 8 weeks prior to treatment; 5. Signed informed consent form and informed of the specific trial protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with failed H. pylori eradication; 2. Pregnant, lactating women; 3. history of malignant tumors of the gastrointestinal tract; 4. history of previous major gastrectomy; 5. severe insufficiency of vital organs such as heart, liver, kidney and lung and congenital diseases; e.g. class IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.; 6. Those who are allergic to the drugs used; 7. refusal of the guardian or patient to be enrolled; 8. persons with alcohol and/or drug abuse (addiction or dependence) or poor compliance as judged by the physician; 9. Persons with legal incapacity or poor self-awareness.

Design outcomes

Primary

MeasureTime frame
Eradication rate;

Secondary

MeasureTime frame
Incidence of side effects;Resistance rate of H. pylori;Compliance rate;Change in symptom scores;Reinfection rate;

Countries

China

Contacts

Public ContactYingjie Ji

Shanghai East Hospital

jiyingjie39@outlook.com+86 158 0057 5527

Outcome results

None listed

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