H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy

February 22, 2022 updated by: Jun-Hyung Cho, Soonchunhyang University Hospital

Comparison of Helicobacter Pylori Treatment Between Modified Quadruple Therapy and Tailored Eradication Based on the Presence of Clarithromycin Resistance

The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment.

Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.

Study Type

Observational

Enrollment (Actual)

270

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 04401
        • Digestive Disease Center, Soonchunhyang University Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

H. pylori-infected patients

Description

Inclusion Criteria:

  • Gastroscopy can be performed
  • H. pylori test and pathological analysis can be performed

Exclusion Criteria:

  • Age < 20 or > 80 years
  • Anemia (serum hemoglobin level < 10 g/dL)
  • Severe systemic disease
  • Advanced chronic liver disease
  • Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
  • History of H. pylori eradication
  • History of gastric surgery
  • Recent history of upper gastrointestinal bleeding

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Modified quadruple therapy
pantoprazole 40mg bid, amoxicillin 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 14 days
Drug: H. pylori eradication
Antimicrobial agents for H. pylori eradication
Tailored eradication
pantoprazole 40mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid or pantoprazole 40mg bid, tetracycline 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 7 days
Drug: H. pylori eradication
Antimicrobial agents for H. pylori eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H. pylori infection status
Time Frame: 6 weeks
Rate of successful H. pylori eradication
6 weeks

Collaborators and Investigators

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

Sponsor

Soonchunhyang University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2018

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • SCH-HP-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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