Tailored H. Pylori Eradication Based on Clarithromycin Resistance

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection; Antibiotic Resistant Strain
• Intervention / Treatment: Drug: proton pump inhibitor, amoxicillin, metronidazole; Drug: proton pump inhibitor, amoxicillin, clarithromycin

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 Type: Observational
• Enrollment (Actual): 431

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Helicobacter-pylori positive patients with gastritis, ulcer, adenoma

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PAM-treated clarithromycin-resistance group; 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	Drug: proton pump inhibitor, amoxicillin, metronidazole; clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole
PAC-treated nonresistance group; 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	Drug: proton pump inhibitor, amoxicillin, clarithromycin; non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori eradication rate	Number of participant with successful Helicobacter pylori eradication	2 year

Collaborators and Investigators

• Sponsor: Kangdong Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Amoxicillin; Clarithromycin; Proton Pump Inhibitors
• Other Study ID Numbers: Kangdong2017-03-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No