Rescue Therapy for Helicobacter Pylori Eradication Treatment

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Tetracycline,Metronidazole; Drug: Bismuth Potassium Citrate; Drug: Esomeprazole; Drug: Minocycline,Metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT04531059

rjkls2019013

Details and patient eligibility

About

Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.

Enrollment: 368 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• subjects naive to H. pylori treatment,
• under 18 or over 80 years old
• history of gastrectomy
• pregnant or lactating women
• severe systemic diseases or malignancy
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
• contraindications to the study drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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368 participants in 2 patient groups

Tetracycline Bismuth Quadruple Therapy

Active Comparator group

Description:

Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid

Treatment:

Drug: Esomeprazole

Drug: Bismuth Potassium Citrate

Drug: Tetracycline,Metronidazole

Minocycline Bismuth Quadruple Therapy

Experimental group

Description:

Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid

Treatment:

Drug: Minocycline,Metronidazole

Drug: Esomeprazole

Drug: Bismuth Potassium Citrate