High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Esomeprazole; Drug: Amoxicillin; Drug: Metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT04024527

rjyy20190715

Details and patient eligibility

About

Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.

Enrollment: 306 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 previous treatment failure

Exclusion criteria

• Less than 18 years old or older than 80 years
• 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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306 participants in 2 patient groups

Dual therapy

Active Comparator group

Description:

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

Treatment:

Drug: Esomeprazole

Drug: Amoxicillin

Metronidazole plus dual therapy

Experimental group

Description:

Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Treatment:

Drug: Esomeprazole

Drug: Metronidazole

Drug: Amoxicillin