Tailored H. Pylori Eradication Based on Clarithromycin Resistance

Completed

• Conditions: Antibiotic Resistant Strain; Helicobacter Pylori Infection
• Interventions: Drug: proton pump inhibitor, amoxicillin, clarithromycin; Drug: proton pump inhibitor, amoxicillin, metronidazole

• Registration Number: NCT03884348
• Lead Sponsor: Kangdong Sacred Heart Hospital

Brief 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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Study First Posted: 2019-03-21
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 431

Inclusion Criteria

• Clinical diagnosis of Helicobacter pylori infection

Exclusion Criteria

• H. pylori eradication therapy within 1 year,
• antibiotics within 4 weeks,
• surgery for gastric cancer
• malignant tumors other than gastric cancer
• end-stage renal disease
• liver cirrhosis,
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PAC-treated nonresistance group	proton pump inhibitor, amoxicillin, clarithromycin	Treatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and clarithromycin (500 mg) twice a day for 7 day in patients with clinically insignificant point mutations
PAM-treated clarithromycin-resistance group	proton pump inhibitor, amoxicillin, metronidazole	Treatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and metronidazole (500 mg) three times a day for 7 days in patients with clinically significant point mutations

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	2 year	Number of participant with successful Helicobacter pylori eradication