NCT02732249

Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

A Randomized Clinical Trial of Clarithromycin/Bismuth Containing Quadruple Therapy for Helicobacter Pylori First-line Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Esomeprazole	Given 30 min before morning and evening meals
DRUG	Bismuth Potassium Citrate	Given 30 min before morning and evening meals
DRUG	Clarithromycin	Given 30 min after morning and evening meals
DRUG	Metronidazole	Given 30 min after meals or at bedtime

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-09-30
• Completion: 2017-09-30
• First posted: 2016-04-08
• Last updated: 2018-06-26

Locations

1 site across 1 country: China