NCT05002595

H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy

Comparison of Helicobacter Pylori Treatment Between Modified Quadruple Therapy and Tailored Eradication Based on the Presence of Clarithromycin Resistance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 270 (actual)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment. Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.

Detailed description

The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.

Conditions

• H. Pylori Infection

Interventions

Type	Name	Description
DRUG	H. pylori eradication	Antimicrobial agents for H. pylori eradication

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-08-31
• Completion: 2021-12-31
• First posted: 2021-08-12
• Last updated: 2022-02-24

Locations

1 site across 1 country: South Korea