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Evaluation of the efficacy and safety of a combination regimen containing Vonoprazan in the treatment of Helicobacter pylori infection: a prospective, randomized controlled study

Evaluation of the efficacy and safety of a combination regimen containing Vonoprazan in the treatment of Helicobacter pylori infection: a prospective, randomized controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055752
Enrollment
Unknown
Registered
2022-01-17
Start date
2022-01-17
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Helicobacter pylori

Interventions

14-day dual regimen group:14-day dual regimen with vonoprazan (vonoprazan 20 mg bid + amoxicillin 1 g TID)
14-day quadruple therapy:14-day bismuth containing quadruple therapy (lansoprazole 30 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid + bismuth potassium citrate 600 mg bid)

Sponsors

The first affiliated hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 69 years; 2. The patients with Helicobacter pylori infection were determined to be positive by at least the following two methods: rapid urease test, histopathology, HP culture and fecal HP antigen; Or the physical examination found that 13C breath test was positive, and the DOB value close to the critical value was excluded (4 - 8‰); 3. Have not received Helicobacter pylori eradication treatment in the past; 4. Willing to carry out anti HP treatment and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to any of the tested drugs (vonoprazan fumarate and related compounds, proton pump inhibitor (PPI), clarithromycin, amoxicillin, bismuth agent or lansoprazole); 2. Partial or subtotal gastrectomy; 3. Subjects whose liver function test value is 1.5 times higher than the upper limit of normal value; 4. Those who used antibiotics or steroids within 4 weeks before enrollment and PPI or walker within 2 weeks before enrollment; 5. Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
13C-UBT;

Countries

China

Contacts

Public ContactLei Xiaoyi

The first affiliated hospital of Xiamen University

lxyboy78@sina.com+86 15859265923

Outcome results

None listed

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