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Tailored Therapy for Clarithromycin-Resistant H. Pylori

Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03431688
Enrollment
782
Registered
2018-02-13
Start date
2018-10-01
Completion date
2020-12-30
Last updated
2025-09-22

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

Conditions

Helicobacter Pylori Infection

Brief summary

Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.

Interventions

DRUGPAM

treatment with PPI, metonidazole, amoxicillin

DRUGPBMT

treatment with PPI, metonidazole, bismuth, tetracyclin

Sponsors

Kangdong Sacred Heart Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

* peptic ulcer disease * H. pylori gastritis * low grade MALT lymphoma

Exclusion criteria

* history of gastric cancer surgery * severe comorbidity (ESRD, LC) * hypersensitivity to drug * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
H. pylori eradication rate14 daysH. pylori eradication rate

Countries

South Korea

Outcome results

None listed

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