Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06037122
• Other study ID #: 2023-0674
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Qin DU
• Phone: +86 0571-89713734
• Email: duqin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 558
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter H. pylori eradication rate	number of patients successfully eradicated / the total number participants	after eradication therapy at least 4 weeks
Secondary	safety of regimens	comparison of the incidence of adverse events in each group	Within 4 weeks from the beginning to the end of therapy
Secondary	compliance	percentage of correctly administered drugs	4 weeks after therapy completion