NCT05176821

Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection

Eradication Efficacy and Safety of High-dose Dual Therapy Compared With Furazolidone-based Quadruple Therapy as a Rescue Treatment for Helicobacter Pylori Infection: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.

Detailed description

Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies. H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.

Conditions

• H. Pylori Infection

Interventions

Type	Name	Description
DRUG	esomeprazole plus amoxicillin	amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days
DRUG	amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole	amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-01-04
• Last updated: 2022-08-05

Locations

1 site across 1 country: China