Tailored Therapy for Clarithromycin-Resistant H. Pylori | NCT03431688

Studies
Tailored Therapy for Clarithromycin-Resistant H. Pylori

NCT03431688

Sponsor

Kangdong Sacred Heart Hospital

Status

Completed

Last Update Posted

Sep 22, 2025Actual

Enrollment

782Actual

Phase

Not Applicable

Conditions

Helicobacter Pylori Infection

Interventions

PAM
PBMT

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Oct 30, 2020Actual

Completion Date

Dec 30, 2020Actual

First Submitted Date

Jan 31, 2018

First Submission Date that Met QC Criteria

Feb 12, 2018

First Posted Date

Feb 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2025

Last Update Posted Date

Sep 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

782Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PAM	Active Comparator	treatment with PPI, metonidazole, amoxicillin	Drug: PAM
PBMT	Active Comparator	treatment with PPI, metonidazole, bismuth, tetracyclin	Drug: PBMT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PAM	Drug	treatment with PPI, metonidazole, amoxicillin	PAM
PBMT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
H. pylori eradication rate	H. pylori eradication rate	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Woon Geon Shin	Kangdong Sacred Heart Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangdong Sacred Heart Hospital		Seoul		134-701	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided