NCT03884348

Tailored H. Pylori Eradication Based on Clarithromycin Resistance

Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 431 (actual)
• Sponsor: Kangdong Sacred Heart Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations.

Detailed description

Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were considered clinically insignificant. Participants who did not have point mutations related to clarithromycin resistance and/or had clinically insignificant point mutations were treated with PAC (proton pump inhibitor, amoxicillin, clarithromycin) for 7 days, while participants with clinically significant point mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for 7 days. H. pylori eradication rates were compared between the two groups.

Conditions

• Helicobacter Pylori Infection
• Antibiotic Resistant Strain

Interventions

Type	Name	Description
DRUG	proton pump inhibitor, amoxicillin, clarithromycin	non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin
DRUG	proton pump inhibitor, amoxicillin, metronidazole	clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2019-03-21
• Last updated: 2019-03-21