Clinical trial

Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Real-world Evidence Study

Name
rjhy20240001
Description
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. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting.
Trial arms
Trial start
2021-03-01
Estimated PCD
2024-03-30
Trial end
2024-04-30
Status
Completed
Treatment
BQT
PPI(esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, tetracycline 500 mg four times a day, and metronidazole 400 mg four times a day
Arms:
BQT
PBM4M4
PPI(esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg four times a day, and metronidazole 400 mg four times a day
Arms:
PBM4M4
PBM3M3
PPI(esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg three times a day, and metronidazole 400 mg three times a day
Arms:
PBM3M3
PBM2M4
PPI(esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg twice daily, and metronidazole 400 mg four times a day
Arms:
PBM2M4
PBM2M3
PPI(esomeprazole or vonoprazan), bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg twice daily, and metronidazole 400 mg three times a day
Arms:
PBM2M3
Size
823
Primary endpoint
Helicobacter pylori eradication rate
Six weeks after completion of therapy
Eligibility criteria
Inclusion Criteria: * Confirmed H. pylori infection and with previous treatment failure Exclusion Criteria: * subjects naive to H. pylori treatment, * 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 12 weeks
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 823, 'type': 'ACTUAL'}}
Updated at
2024-05-29

1 organization

5 products

1 indication

Product
BQT
Product
PBM4M4
Product
PBM3M3
Product
PBM2M4
Product
PBM2M3