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Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia

Primary Purpose

Dyspepsia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Dyspepsia, Microbiome, Eradication therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who has diagnosed with functional dyspesia by Rome IV criteria

Exclusion Criteria:

  • Known GI malignancy
  • Previous Helicobater pylori eradication history
  • Severe systemic disease
  • Previous GI surgery
  • Uncorrectable coagulopathy: INR > 1.5 or platelet < 50,000/ml
  • Pregnant or breastfeeding women
  • Atrophic gastritis, open type

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HP eradication group

    Arm Description

    HP eradication group Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days

    Outcomes

    Primary Outcome Measures

    Change of gut microbiome
    Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative

    Secondary Outcome Measures

    Symptom of dyspepsia
    Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months
    Eradication of helicobacter pylori
    Eradication rate of helicobacter pylori at 3 months
    Histologic finding of UGI tract
    Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy

    Full Information

    First Posted
    June 22, 2020
    Last Updated
    June 24, 2020
    Sponsor
    Asan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04449185
    Brief Title
    Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
    Official Title
    Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 30, 2020 (Anticipated)
    Primary Completion Date
    October 30, 2021 (Anticipated)
    Study Completion Date
    October 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Asan Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.
    Detailed Description
    Accumulating evidence shows that Helicobacter pylori protects against some metabolic and immunological diseases in which the development of these diseases coincide with temporal or permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve symptoms of functional dyspepsia. The aims of our study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyspepsia
    Keywords
    Dyspepsia, Microbiome, Eradication therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HP eradication group
    Arm Type
    Experimental
    Arm Description
    HP eradication group Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
    Intervention Type
    Drug
    Intervention Name(s)
    Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
    Intervention Description
    Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
    Primary Outcome Measure Information:
    Title
    Change of gut microbiome
    Description
    Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative
    Time Frame
    at 3 months, and 6 months
    Secondary Outcome Measure Information:
    Title
    Symptom of dyspepsia
    Description
    Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months
    Time Frame
    at 3 months, and 6 months
    Title
    Eradication of helicobacter pylori
    Description
    Eradication rate of helicobacter pylori at 3 months
    Time Frame
    at 3 months
    Title
    Histologic finding of UGI tract
    Description
    Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy
    Time Frame
    at initial and 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who has diagnosed with functional dyspesia by Rome IV criteria Exclusion Criteria: Known GI malignancy Previous Helicobater pylori eradication history Severe systemic disease Previous GI surgery Uncorrectable coagulopathy: INR > 1.5 or platelet < 50,000/ml Pregnant or breastfeeding women Atrophic gastritis, open type
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kee Wook Jung, MD, PhD
    Phone
    821026778856
    Email
    jung.keewook30@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ga Hee Kim, MD, PhD
    Phone
    821028732884
    Email
    smallgh@hanmail.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kee Wook Jung, MD, PhD
    Organizational Affiliation
    Asan Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia

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