Helicobacter Pylori Eradication and Follow-up

Fudan University

Status and phase: Enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Amoxicillin; Drug: Metronidazole; Drug: Bismuth potassium citrate; Drug: Clarithromycin; Drug: Levofloxacin; Drug: Rabeprazole; Drug: Doxycycline; Drug: Tetracycline

Study type: Interventional

Funder types: Other

Identifiers

NCT05061732

B2021-376

Details and patient eligibility

About

This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori 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: 4,447 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.

Exclusion criteria

• 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, proton pump inhibitors 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: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,447 participants in 10 patient groups

RBCL

Experimental group

Description:

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days

Treatment:

Drug: Rabeprazole

Drug: Levofloxacin

Drug: Clarithromycin

Drug: Bismuth potassium citrate

RBLM

Experimental group

Description:

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days

Treatment:

Drug: Rabeprazole

Drug: Metronidazole

Drug: Metronidazole

Drug: Levofloxacin

Drug: Bismuth potassium citrate

RBCM

Experimental group

Description:

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days

Treatment:

Drug: Rabeprazole

Drug: Metronidazole

Drug: Metronidazole

Drug: Clarithromycin

Drug: Bismuth potassium citrate

RA

Experimental group

Description:

Rabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days

Treatment:

Drug: Amoxicillin

Drug: Rabeprazole

RAB

Experimental group

Description:

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days

Treatment:

Drug: Amoxicillin

Drug: Rabeprazole

Drug: Bismuth potassium citrate

RAM

Experimental group

Description:

Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days

Treatment:

Drug: Amoxicillin

Drug: Rabeprazole

Drug: Metronidazole

Drug: Metronidazole

RBAM

Experimental group

Description:

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days

Treatment:

Drug: Amoxicillin

Drug: Rabeprazole

Drug: Metronidazole

Drug: Metronidazole

Drug: Bismuth potassium citrate

RBAM4

Experimental group

Description:

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days

Treatment:

Drug: Amoxicillin

Drug: Rabeprazole

Drug: Metronidazole

Drug: Metronidazole

Drug: Bismuth potassium citrate

RBDM

Experimental group

Description:

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days

Treatment:

Drug: Rabeprazole

Drug: Metronidazole

Drug: Doxycycline

Drug: Metronidazole

Drug: Bismuth potassium citrate

RBTM

Active Comparator group

Description:

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days

Treatment:

Drug: Rabeprazole

Drug: Metronidazole

Drug: Tetracycline

Drug: Metronidazole

Drug: Bismuth potassium citrate