NCT03431688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
782

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 22, 2025

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

January 31, 2018

Last Update Submit

September 17, 2025

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • H. pylori eradication rate

    H. pylori eradication rate

    14 days

Study Arms (2)

PAM

ACTIVE COMPARATOR

treatment with PPI, metonidazole, amoxicillin

Drug: PAM

PBMT

ACTIVE COMPARATOR

treatment with PPI, metonidazole, bismuth, tetracyclin

Drug: PBMT

Interventions

PAMDRUG

treatment with PPI, metonidazole, amoxicillin

PAM
PBMTDRUG

treatment with PPI, metonidazole, bismuth, tetracyclin

PBMT

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangdong Sacred Heart Hospital

Seoul, 134-701, South Korea

Location

Study Officials

  • Woon Geon Shin

    Kangdong Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Woon Geon Shin

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 13, 2018

Study Start

October 1, 2018

Primary Completion

October 30, 2020

Study Completion

December 30, 2020

Last Updated

September 22, 2025

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)