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The effect of Helicobacter pylori eradication on small intestinal bacterial overgrowth: A prospective observational study

Status Approved

  • First Submitted Date

    2020/05/20

  • Registered Date

    2020/05/22

  • Last Updated Date

    2020/05/20

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005049
    Unique Protocol ID VC20OISI0047
    Public/Brief Title The effect of Helicobacter pylori eradication on small intestinal bacterial overgrowth: A prospective observational study
    Scientific Title The effect of Helicobacter pylori eradication on small intestinal bacterial overgrowth: A prospective observational study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number VC20OISI0047
    Approval Date 2020-04-09
    Institutional Review Board Name The Institutional Research Ethics Board of St. Vincent’s hospital, Catholic University of Korea
    Institutional Review Board Address 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do
    Institutional Review Board Telephone 031-249-8289
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Chang-Nyol Paik
    Title Professor
    Telephone +82-31-881-8581
    Affiliation The Catholic University of Korea, St. Vincent's Hospital
    Address 93, Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do
    Contact Person for Public Queries
    Name Dae Bum Kim
    Title Assistant professor
    Telephone +82-31-881-8582
    Affiliation The Catholic University of Korea, St. Vincent's Hospital
    Address 93, Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do
    Contact Person for Updating Information
    Name Dae Bum Kim
    Title Assistant professor
    Telephone +82-31-881-8582
    Affiliation The Catholic University of Korea, St. Vincent's Hospital
    Address 93, Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-02 Anticipated
    Target Number of Participant 156
    Primary Completion Date 2022-03-31 , Anticipated
    Study Completion Date 2022-05-12 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, St. Vincent's Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-02 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name IL-YANG Pharmaceuticals
    Organization Type Pharmaceutical Company
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea, St. Vincent's Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Small intestinal bacterial overgrowth means an increase in the number of bacteria in the small bowel or an increase in the amount of abnormal types of bacteria, which can result in complex and diverse symptoms. Small intestinal bacterial overgrowth can show various symptoms of functional dyspepsia and irritable bowel syndrome, such as abdominal distension, gas, abdominal discomfort, diarrhea, and abdominal pain. In severe cases, symptoms of absorption disorders (weight loss, fat stool, malnutrition) may also appear.
    Helicobacter pylori damages the gastrointestinal mucosa defense system and reduces the secretion of gastric acid, Helicobacter pylori infection can cause small intestinal bacterial overgrowth with these mechanisms. Previous studies have reported that Helicobacter pylori infection is associated with small intestinal bacterial overgrowth, and also reports a high incidence of small intestinal bacterial overgrowth in patients treated with Helicobacter pylori infection. Proton pump inhibitors used for Helicobacter pylori eradication can inhibit gastric acid and cause small intestinal bacteria overgrowth, and the antibiotics included in the treatment can contribute to the growth of small intestinal bacteria by inducing the proliferation of non-helicobacter pylori.
    Previous studies have reported that the incidence of small intestinal bacterial overgrowth is high in patients who have simply been treated with Helicobacter pylori, but it is not clear whether the actual bactericidal treatment treats or induces small intestinal bacterial overgrowth. There is also controversy in recent studies as to whether proton pump inhibitors cause small intestinal bacterial overgrowth.
    Therefore, in this study, we investigated the effect of Helicobacter pylori eradication on small intestinal bacterial overgrowth in patients with Helicobacter pylori infection. In addition, we evaluate the changes in small intestinal bacterial overgrowth in patients who have taken proton pump inhibitor alone, patterns of glucose breath test, and changes in concentration of breath hydrogen and methane.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 156
    Cohort/Group Number 3
    Cohort/
    Group 1

    Cohort/Group Label

    Patient with functional gastrointestinal symptoms who have Helicobacter pylori infection and small intestinal bacterial overgrowth

    Cohort/Group Description

    In patients diagnosed with Helicobacter pylori infection and small intestinal bacterial overgrowth after endoscopy and glucose breath test performed for functional gastrointestinal symptoms, Helicobacter pylori status, glucose breath test, and changes of symptoms were monitored after 4 weeks after Helicobacter pylori eradication.
    Cohort/
    Group 2

    Cohort/Group Label

    Patient with functional gastrointestinal symptoms who have Helicobacter pylori infection but no small intestinal bacterial overgrowth

    Cohort/Group Description

    In patients diagnosed with Helicobacter pylori infection but negative results of small intestinal bacterial overgrowth after endoscopy and glucose breath test performed for functional gastrointestinal symptoms, Helicobacter pylori status, glucose breath test, and changes of symptoms were monitored after 4 weeks after Helicobacter pylori eradication.
    Cohort/
    Group 3

    Cohort/Group Label

    Patient with functional gastrointestinal symptoms without Helicobacter pylori infection and without small intestinal bacterial overgrowth

    Cohort/Group Description

    In patients without both Helicobacter pylori infection and small intestinal bacterial overgrowth after endoscopy and glucose breath test performed for functional gastrointestinal symptoms, glucose breath test and changes of symptoms were monitored after 4 weeks after proton pump inhibitor therapy.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients between the ages of 20 and 70 who visited with functional gastrointestinal symptoms and performed endoscopy for Helicobacter pylori infection and glucose breath test
    Sampling Method
    Non-probablity sampling: A complete enumeration of patients between the ages of 20 and 70 who visited with functional gastrointestinal symptoms and performed endoscopy for Helicobacter pylori infection and glucose breath test
    Condition(s)/Problem(s) * (K00-K93)Diseases of the digestive system 
       (K92.9)Disease of digestive system, unspecified 

    Functional gastrointestinal disease Helicobacter pylori infection Small intestinal bacterial overgrowth
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~70Year

    Description

    1) patients of age 20 to 70
    2) patients who visited with functional gastrointestinal symptoms and performed endoscopy for Helicobacter pylori infection and glucose breath test
    Exclusion Criteria
    1) Patients who were treated with antibiotics within 3 months 
    2) Patients diagnosed with gastrointestinal stricture or obstruction at the endoscopy or upper gastrointestinal series 
    3) Patients with previous gastrointestinal surgery, except for appendectomy 
    4) Patients who have gastrointestinal bleeding, mechanical obstruction, or perforation 
    5) Patients who have severe organ dysfunction, such as renal dysfunction or hepatic dysfunction 
    6) Patients who were treated with medication, such as prokinetics, histamine receptor antagonists, proton pump inhibitors, anticholinergics, antidepressant within 2 weeks before the study 
    7) Allergic reaction for experimental medicine 
    8) Improper patient in the study, according to judgement of researcher
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Changes in small intestinal bacterial overgrowth after Helicobacter pylori eradication
    Timepoint
    at 4 weeks after completion of treatment
    Secondary Outcome(s) 1
    Outcome
    The results of glucose breath test
    Timepoint
    at 4 weeks after completion of treatment
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2022. 12
    Way of Sharing Available on Request
    (drkimble@hanmail.net)
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