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Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication

Efficacy and Safety Evaluation of Bismuth-containing Quadruple Therapies Based on Low-dose Vonoprazan in the Initial Treatment of Helicobacter Pylori Infection: a Retrospective Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06037122
Enrollment
558
Registered
2023-09-14
Start date
2023-09-30
Completion date
2024-06-30
Last updated
2023-09-14

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

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori, quadruple regimen, vonoprazan

Brief summary

The primary objective of this retrospective study was to assess the efficacy and safety of a bismuth quadruple regimen of a low-dose potassium-competitive acid blocker versus a standard-dose potassium-competitive acid blocker and a standard-dose proton pump inhibitor combined with amoxicillin and clarithromycin as the initial treatment of Helicobacter pylori infection.

Detailed description

Helicobacter pylori (H. pylori) infection is closely associated with a variety of diseases including chronic gastritis, peptic ulcer, and gastric cancer. Adequate acid suppression is essential for H. pylori eradication therapy. Potassium-competitive acid blocker (P-CAB) vonoprazan (VPZ) has faster, stronger, and longer-lasting acid inhibition and plays an important role in H. pylori treatment. 2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment recommended for the first time a quadruple regimen of bismuth containing P-CAB for H. pylori eradication, in which P-CAB was administered as VPZ 20 mg twice daily. In this retrospective study, we compared the efficacy and safety of a quadruple regimen based on low-dose P-CAB (VPZ 20 mg once daily) versus a quadruple regimen based on standard-dose P-CAB (VPZ 20 mg twice daily) or standard-dose proton pump inhibitor (rabeprazole 10 mg twice daily) containing amoxicillin, clarithromycin, and bismuth as initial treatment for H. pylori infection. Our study will provide clinical evidence for the necessary dosage of VPZ in bismuth quadruple regimens, which will help to further optimize the treatment regimen for H. pylori infection.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Diagnosis of H. pylori infection confirmed by urea breath test, monoclonal fecal antigen test, endoscopic biopsy histopathology, or bacterial culture; 2. No previous eradication therapy for H. pylori; 3. Age and gender are not restricted.

Exclusion criteria

1. Use of acid-suppressing drugs within 2 weeks prior to treatment, or use of bismuth or antibiotics (including herbal medicines with antimicrobial properties) within 4 weeks prior to treatment; 2. Known hypersensitivity to the drugs used in this study; 3. History of esophageal or gastric surgery; 4. Pregnant or lactating women; 5. Serious systemic diseases, diseases of the heart, lungs, brain and other vital organs, hepatic or renal insufficiency or malignant tumors (except gastric cancer); 6. Patients unable to express their main complaints.

Design outcomes

Primary

MeasureTime frameDescription
Helicobacter H. pylori eradication rateafter eradication therapy at least 4 weeksnumber of patients successfully eradicated / the total number participants

Secondary

MeasureTime frameDescription
safety of regimensWithin 4 weeks from the beginning to the end of therapycomparison of the incidence of adverse events in each group
compliance4 weeks after therapy completionpercentage of correctly administered drugs

Contacts

Primary ContactQin DU
duqin@zju.edu.cn+86 0571-89713734

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026