NCT06332599

Minocycline for Helicobacter Pylori Rescue Treatment

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 823 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	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
DRUG	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
DRUG	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
DRUG	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
DRUG	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

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-03-30
• Completion: 2024-04-30
• First posted: 2024-03-27
• Last updated: 2024-12-30

Locations

1 site across 1 country: China