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

Phase 4

Not yet recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Vonoprazan; Drug: Amoxicillin, Metronidazole; Drug: Bismuth Potassium Citrate; Drug: Esomeprazole

• Registration Number: NCT05726734
• Lead Sponsor: Shanghai East Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Study Start: 2023-02-06
• Study First Posted: 2023-02-14
• Last Update Posted: 2023-02-14
• Primary Completion: 2025-02-06
• Study Completion: 2026-02-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vonoprazan-containing Triple Therapy	Amoxicillin, Metronidazole	Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Empiric Bismuth Quadruple Therapy	Amoxicillin, Metronidazole	Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Empiric Bismuth Quadruple Therapy	Bismuth Potassium Citrate	Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Vonoprazan-containing Triple Therapy	Vonoprazan	Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Empiric Bismuth Quadruple Therapy	Esomeprazole	Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	Six weeks after completion of therapy	Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

Secondary Outcome Measures

Name	Time	Method
Compliance rate	Within 7 days after completion of therapy	Compliance was defined as poor when they had taken less than 80% of the total medication
Rate of adverse effects	Within 7 days after completion of therapy	The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)

Trial Locations

Locations (1)

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China