High Dose of Amoxicillin and Metronidazole 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: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Amoxicillin, Metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03557437

rjkls2018037

Details and patient eligibility

About

Amoxicillin and metronidazole （400mg Q.D.S） based quadruple 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 amoxicillin and metronidazole (400mg thrice a day) based triple therapy and the addition of bismuth in the naive patients with helicobacter pylori infection.

Enrollment: 216 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 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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216 participants in 2 patient groups

Triple Therapy

Active Comparator group

Description:

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

Treatment:

Drug: Amoxicillin, Metronidazole

Drug: Esomeprazole

Bismuth Plus Triple 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: Amoxicillin, Metronidazole

Drug: Esomeprazole