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Optimal Tailored Treatment for H. Pylori Infection

Primary Purpose

Helicobacter Pylori Infection, Antibiotic Resistant Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)
Sponsored by
Incheon St.Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of H pylori infection

Exclusion Criteria:

  • subjects younger than 18 years old
  • subjects with a history of H pylori eradication
  • subjects who had previous gastric surgery
  • subjects who were pregnant or lactating
  • subjects with serious concurrent illness
  • subjects who were administered antibiotics, bismuth, or PPIs in the 8 weeks preceding the study
  • subjects with a history of allergy to any one of the compounds in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Empirical therapy for H. pylori infection

    Tailored therapy for H. pylori infection

    Arm Description

    The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication

    The tailored therapy group receives eradication regimens based on their DPO-PCR results. Triple therapy of 7 or 14 days for clarithromycin sensitive patients based on DPO-PCR and bismuth quadruple therapy of 7 or 14 days for clarithromycin resistant patients based on DPO-PCR.

    Outcomes

    Primary Outcome Measures

    Eradication success
    H. pylori eradication success based on urea breath test

    Secondary Outcome Measures

    Full Information

    First Posted
    June 28, 2020
    Last Updated
    July 4, 2020
    Sponsor
    Incheon St.Mary's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04462133
    Brief Title
    Optimal Tailored Treatment for H. Pylori Infection
    Official Title
    Optimal Tailored Treatment for H. Pylori Infection According to the Presence of DPO-PCR Based Clarithromycin Resistance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Incheon St.Mary's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was introduced and made commercially available. The primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. Specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.
    Detailed Description
    Patients are randomly assigned to the empirical therapy group and tailored therapy group. The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy group receives treatment based on their DPO-PCR results. Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7 or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth quadruple therapy for 7 or 14 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Helicobacter Pylori Infection, Antibiotic Resistant Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Empirical treatment versus tailored therapy
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1988 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Empirical therapy for H. pylori infection
    Arm Type
    Active Comparator
    Arm Description
    The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication
    Arm Title
    Tailored therapy for H. pylori infection
    Arm Type
    Experimental
    Arm Description
    The tailored therapy group receives eradication regimens based on their DPO-PCR results. Triple therapy of 7 or 14 days for clarithromycin sensitive patients based on DPO-PCR and bismuth quadruple therapy of 7 or 14 days for clarithromycin resistant patients based on DPO-PCR.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)
    Intervention Description
    Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results
    Primary Outcome Measure Information:
    Title
    Eradication success
    Description
    H. pylori eradication success based on urea breath test
    Time Frame
    8-12 weeks after eradication

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of H pylori infection Exclusion Criteria: subjects younger than 18 years old subjects with a history of H pylori eradication subjects who had previous gastric surgery subjects who were pregnant or lactating subjects with serious concurrent illness subjects who were administered antibiotics, bismuth, or PPIs in the 8 weeks preceding the study subjects with a history of allergy to any one of the compounds in this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Byung-Wook Kim, MD, PhD
    Phone
    82-32-280-5057
    Email
    gastro@catholic.ac.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Byung-Wook Kim, MD, PhD
    Organizational Affiliation
    Incheon St.Mary's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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