High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Bismuth Potassium Citrate; Drug: Esomeprazole; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT03405584

rjkls2017196

Details and patient eligibility

About

Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin. Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori treatment.This study is designed to evaluate the efficacy and safety of the addition of bismuth to high dose of dual therapy for H. pylori eradication.

Enrollment: 160 patients

Sex: All

Ages: 18 to 80 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

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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160 participants in 2 patient groups

Bismuth Plus Dual Therapy

Experimental group

Description:

Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Bismuth Potassium Citrate 600mg bid for 14 days.

Treatment:

Drug: Bismuth Potassium Citrate

Drug: Amoxicillin

Drug: Esomeprazole

Dual Therapy

Active Comparator group

Description:

Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days.

Treatment:

Drug: Amoxicillin

Drug: Esomeprazole