Doxycycline for Helicobacter Pylori Rescue Treatment

Shanghai Jiao Tong University School of Medicine

Status and phase: Enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Tetracycline; Drug: Doxycycline; Drug: Metronidazole; Drug: Esomeprazole; Drug: Bismuth Potassium Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05874570

rjhy20230002

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 doxycycline.

Enrollment: 368 estimated patients

Sex: All

Ages: 18 to 70 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

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 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid

Treatment:

Drug: Bismuth Potassium Citrate

Drug: Esomeprazole

Drug: Metronidazole

Drug: Tetracycline

Doxycycline Bismuth Quadruple Therapy

Experimental group

Description:

Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Doxycycline 100mg bid, Metronidazole 400mg qid

Treatment:

Drug: Bismuth Potassium Citrate

Drug: Esomeprazole

Drug: Metronidazole

Drug: Doxycycline