NCT05874544

Rescue Therapy for Helicobacter Pylori Infection

Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.

Conditions

• Helicobacter Pylori Infection

Interventions

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

Timeline

• Start date: 2023-05-16
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2023-05-25
• Last updated: 2025-09-15

Locations

3 sites across 1 country: China