Clinical trial NCT06037122: Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori
quadruple regimen
vonoprazan
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 558
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of patients undergoing initial treatment for H. pylori infection who attended the outpatient clinic of the Department of Gastroenterology at the Second Hospital of Zhejiang University School of Medicine from January 1, 2021 to December 31, 2021. Only patients using a quadruple regimen based on rabeprazole or vonoprazan combined with amoxicillin and clarithromycin with bismuth were included in the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Helicobacter H. pylori eradication rate
timeFrame: after eradication therapy at least 4 weeks
Secondary outcomes:
measure: safety of regimens
timeFrame: Within 4 weeks from the beginning to the end of therapy
measure: compliance
timeFrame: 4 weeks after therapy completion
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University, School of Medicine
name: Qin DU
role: STUDY_CHAIR
References: