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CompletedNCT03431688Updated Sep 22, 2025

Tailored Therapy for Clarithromycin-Resistant H. Pylori

An interventional study of PAM and PBMT in Helicobacter Pylori Infection, sponsored by Kangdong Sacred Heart Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Kangdong Sacred Heart Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
782
Allocation
Randomized
Ages
19 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Helicobacter Pylori Infection
03

In context

Lead sponsor

Kangdong Sacred Heart Hospital is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • history of gastric cancer surgery
  • severe comorbidity (ESRD, LC)
  • to drug
  • pregnancy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
782 participants (actual)

Study arms

  • Active comparator
    PAM

    treatment with PPI, metonidazole, amoxicillin

    Drug: PAM

  • Active comparator
    PBMT

    treatment with PPI, metonidazole, bismuth, tetracyclin

    Drug: PBMT

Interventions

  • DrugPAM

    treatment with PPI, metonidazole, amoxicillin

  • DrugPBMT

    treatment with PPI, metonidazole, bismuth, tetracyclin

06

What researchers measure

Primary outcomes

  1. H. pylori eradication rate

    H. pylori eradication rate

    Time frame: 14 days

07

Study locations

1 site
  • Kangdong Sacred Heart Hospital
    Seoul, 134-701, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03431688
Lead sponsor
Kangdong Sacred Heart Hospital
Responsible party
Shin, Woon Geon (Woon Geon Shin, Kangdong Sacred Heart Hospital) — Principal investigator
First posted
Feb 13, 2018
Start date
Oct 1, 2018
Primary completion
Oct 30, 2020
Completion
Dec 30, 2020
Last update
Sep 22, 2025

Study contacts

Woon Geon Shin
principal investigator · Kangdong Sacred Heart Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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