Genotypic Resistance Guided Versus Susceptibility Testing Guided Therapy for the First-line Eradication of H. Pylori

October 28, 2018 updated by: National Taiwan University Hospital

Comparison of Genotypic Resistance Guided Versus Susceptibility Testing Guided Therapy for the First-line Eradication of H. Pylori- a Multicenter Randomized Trial

We aimed to (1) compare the efficacy of genotypic resistance guided sequential therapy vs. susceptibility testing guided therapy in the first-line therapy (2) assess the long term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors in this multi-center, open labeled trial

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: Recent trials have shown that susceptibility testing guided therapy was more effective than empirical triple therapy given for 7-10 days in the first-line treatment of H. pylori infection. However, susceptibility testing is time consuming and inconvenient, limiting the widespread application of susceptibility testing guided therapy in clinical practice. Recently, point mutations at 23S rRNA and gyrase A have reported to be associated with clarithromycin and levofloxacin resistance. However, whether genotypic resistance guided therapy is more effective or non-inferior to susceptibility guided therapy has not been reported. Besides, the long term impact of H. pylori eradication on the gut microbiota and metabolic disorders remains unclear. Aim: Therefore, we aimed to (1) compare the efficacy of genotypic resistance guided sequential therapy vs. susceptibility testing guided therapy in the first-line therapy(2) assess the long term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factorsMethods: This will be a multi-center, open labeled trialPatients: 560 patients with H. pylori infection naïve to eradication therapy will be enrolled Testing for H. pylori infectionBefore First Line TreatmentAny two positive of CLO test, histology, HpSA, and culture will be considered as H. pylori infectedAfter First-Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8 weeks after first line therapy. Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year after eradication therapy Determination of antibiotic resistance of H. pylori: E-test will be used to determine the minimum inhibitory concentrations of clarithromycin and levofloxacin to guide the selection of antibiotics. Agar dilution test will also be done. Mutations in 23S rRNA and gyrase A will also be determined by PCR followed by direct sequencing Treatment regimens and assignment Eligible patients will be randomized to receive either one of the treatments (A) Genotypic resistance guided therapy: In the absence of 23S rRNA mutation, clarithromycin based sequential therapy will be given. In the presence of 23S rRAN mutation but the absence of gyrase A mutation, levofloxacin based sequential therapy will be given. In the presence of both 23S rRNA and gyrase A mutations or if genotyping fails, bismuth quadruple therapy will be given. (B) Susceptibility testing guided therapy: In the absence of clarithromycin resistance, clarithromycin based sequential therapy will be given. In the presence of clarithromycin resistance but the absence of levofloxacin resistance, levofloxacin based sequential therapy will be given. In the presence of both clarithromycin and levofloxacin resistance or if culture fails, bismuth quadruple therapy will be given. The stool samples will be collected before, and 2 and 8 weeks and 1 year after eradication therapy to analyze the changes in the antibiotic resistance and microbiota of gut floraThe body weight, waist and hip circumference and serum lipid profile, sugar, and HbA1C levels will be collected before and 8 weeks and 1 year after eradication therapy.

Study Type

Interventional

Enrollment (Anticipated)

560

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 Locations

  • Taiwan
      • Yun-Lin County, Taiwan
        • Recruiting
        • National Taiwan University Hospital, Yun-Lin Branch
        • Contact:
          • Chieh-Chang Chen, MD
        • Principal Investigator:
          • Chieh-Chang Chan, MD
        • Sub-Investigator:
          • Ji-Yuh Lee, MD
        • Sub-Investigator:
          • Yu-Jen Fang, MD
        • Principal Investigator:
          • Chi-Yang Chang, 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients aged greater than 20 years with H. pylori infection naïve to treatment are considered eligible for enrollment..

Exclusion Criteria:

  • children and teenagers aged less than 20 years
  • history of gastrectomy
  • gastric malignancy, including adenocarcinoma and lymphoma
  • previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole, bismuth) and prompt pump inhibitors (esomeprazole)
  • contraindication to treatment drugs
  • pregnant or lactating women
  • severe concurrent disease

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: Genotypic resistance guided therapy
In the absence of 23S rRNA mutation, clarithromycin based sequential therapy will be given. In the presence of 23S rRAN mutation but the absence of gyrase A mutation, levofloxacin based sequential therapy will be given. In the presence of both 23S rRNA and gyrase A mutations or if genotyping fails, bismuth quadruple therapy will be given.
Drug: GGT
In the absence of 23S rRNA mutation, clarithromycin based sequential therapy will be given. In the presence of 23S rRAN mutation but the absence of gyrase A mutation, levofloxacin based sequential therapy will be given. In the presence of both 23S rRNA and gyrase A mutations or if genotyping fails, bismuth quadruple therapy will be given
Active Comparator: Susceptibility testing guided therapy
Tailored therapy according to the minimum inhibitory concentration result (susceptibility testing, E-test)
Drug: SGT
In the absence of clarithromycin resistance, clarithromycin based sequential therapy will be given. In the presence of clarithromycin resistance but the absence of levofloxacin resistance, levofloxacin based sequential therapy will be given. In the presence of both clarithromycin and levofloxacin resistance or if culture fails, bismuth quadruple therapy will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses
Time Frame: 6 weeks
Urea breath testing will be done at least 6 weeks after completion of eradication therapy
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse effects during eradication therapies
Time Frame: 2 weeks
a standard interview will be arranged at the end of treatment to assess the adverse effects
2 weeks

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-Ming Liou, 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)

March 29, 2018

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 28, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201706038MINC

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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