Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection

Zhejiang University

Status and phase: Enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Amoxicillin; Drug: Colloidal bismuth pectin; Drug: Vonoprazan; Drug: Clarithromycin; Drug: Rabeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05419674

2022-0323

Details and patient eligibility

About

This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.

Enrollment: 393 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹⁴C-urea breath test and/or biopsy；
2. underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment；
3. with no historical treatment for helicobacter pylori infection.

Exclusion criteria

1. administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion
2. with previous esophageal or gastric surgery
3. with severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
4. allergy to any of the study drugs
5. participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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393 participants in 3 patient groups

groupA: dual therapy (vonoprazan+amoxicillin)

Experimental group

Description:

vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days

Treatment:

Drug: Amoxicillin

Drug: Vonoprazan

group B: dual therapy (rabeprazole+amoxicillin)

Experimental group

Description:

rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days

Treatment:

Drug: Amoxicillin

Drug: Rabeprazole

group C: bismuth-containing quadruple therapy

Active Comparator group

Description:

rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days

Treatment:

Drug: Amoxicillin

Drug: Colloidal bismuth pectin

Drug: Clarithromycin

Drug: Rabeprazole