NCT04531059

Rescue Therapy for Helicobacter Pylori Eradication Treatment

Rescue Therapy for Helicobacter Pylori Eradication: a Randomized Non-Inferiority Trial of Minocycline or Tetracycline in Bismuth Quadruple Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 368 (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. 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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Esomeprazole	Proton pump inhibitor
DRUG	Bismuth Potassium Citrate	Gastric mucosal protective drug with anti-H. pylori effect
DRUG	Tetracycline,Metronidazole	Antibiotics for H. pylori eradication
DRUG	Minocycline,Metronidazole	Antibiotics for H. pylori eradication

Timeline

• Start date: 2020-10-15
• Primary completion: 2022-12-20
• Completion: 2022-12-31
• First posted: 2020-08-28
• Last updated: 2024-12-30

Locations

3 sites across 1 country: China