Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial

Tongji University

Status and phase: Not yet enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Amoxicillin, Metronidazole; Drug: Vonoprazan; Drug: Bismuth Potassium Citrate; Drug: Esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05726734

2022150

Details and patient eligibility

About

Vonoprazan Amoxicillin and metronidazole based triple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the Vonoprazan, amoxicillin and metronidazole based triple therapy and the empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with non-ulcer functional dyspepsia or peptic ulcer disease
• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection and with no previous treatment experience

Exclusion criteria

• Less than 18 years old
• With previous gastric surgery
• Major systemic diseases
• Pregnancy or lactation
• Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Vonoprazan-containing Triple Therapy

Active Comparator group

Description:

Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Treatment:

Drug: Vonoprazan

Drug: Amoxicillin, Metronidazole

Empiric Bismuth Quadruple Therapy

Experimental group

Description:

Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Treatment:

Drug: Bismuth Potassium Citrate

Drug: Esomeprazole

Drug: Amoxicillin, Metronidazole