Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection

April 12, 2026 updated by: National Taiwan University Hospital

Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection - A Prospective Randomized, Comparative Study

The prevalence of H. pylori antibiotic resistance has reached an alarming level worldwide. Antibiotic stewardship programs should be urgently developed and implemented. However, H. pylori antimicrobial susceptibility testing (AST) is rarely offered, making local resistance patterns not easily available. Guideline-recommended empiric therapies (GR-ET) may no longer reliably achieve high cure rate in the era of increasing antibiotic resistance. susceptibility-guided tailored therapy (SG-TT) may be a good choice to solve this problem.

The aims of this study are:

  1. to compare the efficacy of SG-TT with GR-ET as rescue regimens for H. pylori eradication;
  2. to compare the patient adherence and adverse effects of these treatment regimens;
  3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective multicenter randomized comparative study will be conducted at the National Taiwan University Hospital, NTUH Bei-Hu Branch, NTUH Hsin-Chu Branch, Taipei City Hospital Renai Branch, Buddhist Tzu Chi General Hospital, and Mennonite Christian Hospital in Hualien. The study protocol will be approved by the independent ethics boards or committees of each hospital. Patients, aged >= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. If the patients failed anti-H. pylori therapy previously, these patients will be invited to enter this study for evaluating the efficacy of these rescue regimens.

A computed generated random numbers sequence will be blocked (1:1; block size 6) into two subgroups, say A, and B. After giving written informed consent, each patient will be randomly allocated, to one of two treatment groups:

group A - SG-TT (susceptibility-guided tailored therapy) : treated with 1. clarithromycin triple therapy, or 2. levofloxacin triple therapy, or 3. metronidazole triple therapy, or 4. high-dose dual therapy, or 5. bismuth quadruple therapy, by priority order base on the selection principal through AST with MIC profile;

group B -GR-ET (guidelines-recommended empiric therapy): treated with bismuth quadruple therapy.

All patients will be asked to complete a questionnaire and to record symptoms and drug consumption, and diet content daily during the treatment period. Post-treatment, the patients will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effects of treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test (UBT). The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 4

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 Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients, aged >= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. If the patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue regimens.

Exclusion Criteria:

  1. pregnant or nursing woman;
  2. serious concomitant illness and malignant tumor of any kind;
  3. history of hypersensitivity to test drugs；
  4. serious bleeding during the course of this ulcer;
  5. previous gastric surgery;
  6. receiving bismuth salts, PPIs, or antibiotics in the previous month.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: susceptibility-guided tailored therapy (Group A)

Includes 5 treatment options. The priority order of treatment regimens is based on the selection principal through AST with MIC profile.

1. clarithromycin triple therapy: include rabeprazole 20mg bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid, for 14 days; or 2. levofloxacin triple therapy: include rapeprazole 20 mg bid, amoxicillin 1 g bid, and levofloxacin 500 mg bid, for 14 days; or 3. metronidazole triple therapy: include rabeprazole 20 mg bid, amoxicillin 500 mg qid, and metronidazole 250 mg qid, for 14 days; or 4. high-dose dual therapy: include rabeprazole 20 mg qid, amoxicillin 750 mg qid, for 14 days; or 5. bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.
Drug: susceptibility-guided tailored therapy (Group A)

Includes 5 treatment options. The priority order of treatment regimens is based on the selection principal through AST with MIC profile.

1. clarithromycin triple therapy: include rabeprazole 20mg bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid, for 14 days; or 2. levofloxacin triple therapy: include rapeprazole 20 mg bid, amoxicillin 1 g bid, and levofloxacin 500 mg bid, for 14 days; or 3. metronidazole triple therapy: include rabeprazole 20 mg bid, amoxicillin 500 mg qid, and metronidazole 250 mg qid, for 14 days; or 4. high-dose dual therapy: include rabeprazole 20 mg qid, amoxicillin 750 mg qid, for 14 days; or 5. bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.

Other Names:
  • Proton pump inhibitor: Rabeprazole, Pariet®
  • Antibiotics: Amoxicillin, Amoxicillin®; Clarithromycin, Klaricid®; Levofloxacin, Cravit®; Metronidazole, Metrozole®; Tetracyclline, tetracycline®
  • Colloidal Bismuth: Tripotassium dicitrate bismuthate, KCB®
Active Comparator: guidelines-recommended empiric therapy (Group B)
bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.
Drug: guidelines-recommended empiric therapy (Group B)
bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.
Other Names:
  • Proton pump inhibitor: Rabeprazole, Pariet®
  • Colloidal Bismuth: Tripotassium dicitrate bismuthate, KCB®
  • Antibiotics: Metronidazole, Metrozole®; Tetracyclline, tetracycline®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to compare the eradication rate of SG-TT with GR-ET as rescue regimens for H. pylori eradication.
Time Frame: 3.5 years
The eradication rate (efficacy) of these regimens will be evaluated by the result of C13-UBT in intention-to treat (ITT) and per-protocol (PP) analysis.
3.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to compare the patient adherence and frequency of adverse effects of these treatment regimens
Time Frame: 3.5 years
The frequency of adverse events will be evaluated by the number of participant with adverse events and patient adherence will be evaluated by counting unused medication after the treatment.
3.5 years

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Jyh-Chin Yang, M.D.Ph.D., National Taiwan University 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)

April 11, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 10, 2022

First Submitted That Met QC Criteria

April 10, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202112229MINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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