Tetracycline Versus Doxycycline for HP Rescue Therapy

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Doxycycline; Drug: Metronidazole; Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Tetracycline

Study type: Interventional

Funder types: Other

Identifiers

NCT05018923

B2021-3763

Details and patient eligibility

About

This randomized controlled clinical trial will evaluate the efficacy and safety of proton pump inhibitor, bismuth, metronidazole, and either tetracycline or doxycycline for Helicobacter pylori rescue treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori.

Enrollment: 242 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 failed eradication treatment before.

Exclusion criteria

• Have not 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: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

RBMD group

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: Metronidazole

Drug: Rabeprazole

Drug: Bismuth potassium citrate

Drug: Doxycycline

RAMT group

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: Metronidazole

Drug: Tetracycline

Drug: Rabeprazole

Drug: Bismuth potassium citrate