PPI-amoxicillin for H. Pylori Treatment

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Rabeprazole; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT05014685

B2021-3761

Details and patient eligibility

About

This randomized controlled clinical trial will identify the additional benefit of bismuth or metronidazole in proton pump inhibitor-amoxicillin-containing therapy for Helicobacter pylori first-line treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.

Enrollment: 732 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
• 18-75 years old on the day of signing the ICF.
• Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
• Have not received Helicobacter pylori eradication treatment before.

Exclusion criteria

• Have received Hp eradication treatment.
• Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
• Subjects or guardians refused to participate in the trial.
• Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
• Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
• Pregnant or lactating women.
• Active peptic ulcer.
• allergic to drugs used in the trial.
• any other circumstances that are not suitable for recruitment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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732 participants in 4 patient groups

RA group

Experimental group

Treatment:

Drug: Amoxicillin

Drug: Rabeprazole

RAM group

Experimental group

Treatment:

Drug: Amoxicillin

Drug: Rabeprazole

Drug: Metronidazole

RAB group

Experimental group

Treatment:

Drug: Amoxicillin

Drug: Rabeprazole

Drug: Bismuth potassium citrate

RABM group

Active Comparator group

Treatment:

Drug: Amoxicillin

Drug: Rabeprazole

Drug: Bismuth potassium citrate

Drug: Metronidazole