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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03884348
Enrollment
431
Registered
2019-03-21
Start date
2017-01-01
Completion date
2018-12-31
Last updated
2019-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistant Strain, Helicobacter Pylori Infection

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.

Interventions

DRUGproton pump inhibitor, amoxicillin, clarithromycin

non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin

DRUGproton pump inhibitor, amoxicillin, metronidazole

clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole

Sponsors

Kangdong Sacred Heart Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Helicobacter pylori eradication rate2 yearNumber of participant with successful Helicobacter pylori eradication

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026