NCT06299605

Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori

Triple Versus Quadruple Therapy with Amoxicillin and Tetracycline for the Eradication of Helicobacter Pylori: a Multicenter Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

Detailed description

H. pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention: 14-day quadruple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days 14-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 14 days 7-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment, 13C-urea breath test was tested for confirmation. The eradication rates, adverse reaction rates and patient adherence were calculated and analysed, and the results were analysed to provide more information for eradication regimens of H. pylori.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days	Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days
DRUG	Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days	Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days
DRUG	Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days	Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days

Timeline

• Start date: 2024-11-27
• Primary completion: 2025-10-01
• Completion: 2025-11-30
• First posted: 2024-03-08
• Last updated: 2024-12-03

Locations

1 site across 1 country: China