Tailored Therapy for Clarithromycin-Resistant H. Pylori

March 5, 2019 updated by: Shin, Woon Geon, Kangdong Sacred Heart Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

660

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 134-701
        • Recruiting
        • Kangdong Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Woon Geon Shin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PAM
treatment with PPI, metonidazole, amoxicillin
Drug: PAM
treatment with PPI, metonidazole, amoxicillin
ACTIVE_COMPARATOR: PBMT
treatment with PPI, metonidazole, bismuth, tetracyclin
Drug: PBMT
treatment with PPI, metonidazole, bismuth, tetracyclin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangdong Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ANTICIPATED)

December 30, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (ACTUAL)

February 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KangdongSHH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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