NCT03658733

A Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection

Efficacy and Safety of a 14-day Modified Sequential Therapy for Refractory Helicobacter Pylori Infection: an Open Randomized Pilot Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess efficacy of a new 14-day sequential therapy for the rescue treatment of refractory Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates. The researchers also want to testify whether a double-dose rabeprazole has equal efficacy to double-dose esomeprazole to provide sufficient acid inhibition.

Detailed description

Half of the world's population is infected with Helicobacter pylori. Strong evidence supports that H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly emerging antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. Traditional sequential therapy failed to achieve an ideal eradication rates (over\>95%) as a third line treatment in the region with high antibiotic resistance. This study aims to evaluate the efficacy of 14-day modified sequential therapy in the patients with two or more treatment failure, and whether the adverse effects of this new modified sequential therapy are tolerable. Then, this study will also compare the performance of a double-dose esomeprazole with double-dose rabeprazole containing therapy to optimize therapeutic regimen.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	esomeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)	Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy containing esomeprazole for the Helicobacter pylori eradication. The regimen contains a double dose esomeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by esomeprazole, amoxicillin , tetracycline and colloidal bismuth pectin for the second 7 days.
DRUG	rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)	Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy containing rabeprazole for the Helicobacter pylori eradication. The regimen contains a double-dose rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole, amoxicillin , tetracycline and colloidal bismuth pectin for the second 7 days.

Timeline

• Start date: 2018-12-15
• Primary completion: 2019-08-31
• Completion: 2019-10-31
• First posted: 2018-09-05
• Last updated: 2018-12-04

Locations

1 site across 1 country: China