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Efficacy and Safety of Lactobacillus acidophilus YT1 Probiotics on menopausal symptoms; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status Approved

  • First Submitted Date

    2018/03/12

  • Registered Date

    2018/09/21

  • Last Updated Date

    2018/03/23

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
    KCT0003211
    Unique Protocol ID KUH1040060
    Public/Brief Title Efficacy and Safety of Lactobacillus acidophilus YT1 Probiotics on menopausal symptoms; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
    Scientific Title Efficacy and Safety of Lactobacillus acidophilus YT1 Probiotics on menopausal symptoms; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
    Acronym KFRI_YT1
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KUH1040060
    Approval Date 2017-05-11
    Institutional Review Board Name KONKUK UNIVERSITIY MEDICAL CENTER IRB
    Institutional Review Board Address 120-1, Neungdong-ro, Gwangjin-gu, Seoul
    Institutional Review Board Telephone 02-2030-6522
    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 Lee Ji Young
    Title professor
    Telephone +82-2-2030-7643
    Affiliation Konkuk University Medical Center
    Address 120-1, Neungdong-ro, Gwangjin-gu, Seoul
    Contact Person for Public Queries
    Name Lee Ji Young
    Title professor
    Telephone +82-2-2030-7643
    Affiliation Konkuk University Medical Center
    Address 120-1, Neungdong-ro, Gwangjin-gu, Seoul
    Contact Person for Updating Information
    Name Kim Da Young
    Title employee
    Telephone +82-2-2277-3935
    Affiliation Neonutra
    Address 4F, UPA B/D, 44 Daehak-ro, Jongno-gu, Seoul, Korea
  • 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 Multi-center Number of center : 2
    Overall Recruitment Status Completed
    Date of First Enrollment 2017-06-12 Actual
    Target Number of Participant 80
    Primary Completion Date 2018-01-04 , Actual
    Study Completion Date 2018-03-12 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study National Cancer Center
    Recruitment Status Completed
    Date of First Enrollment 2017-09-04 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Konkuk University Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2017-06-12 ,
  • 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 Korea Food Research Institute
    Organization Type Others
    Project ID KFRI_YT1
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea Food Research Institute
    Organization Type Others
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The purpose of this study was to evaluate the efficacy and safety of Lactobacillus acidophilus YT1 in menopausal women compared with placebo in improving menopausal symptoms.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Supportive Care
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator, Caregiver, Outcome Accessor
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    Lactobacillus acidophilus YT1 2 g / cell and placebo were randomly assigned to receive one dose (once per day) for 12 weeks (one dose) (without water) or with water
    Number of Arms 2
    Arm 1

    Arm Label

    Lactobacillus acidophilus YT1

    Target Number of Participant

    40

    Arm Type

    Experimental

    Arm Description

    For a total of 12 weeks, Take 2 tablets 1 time a day (without water) or with water
    Arm 2

    Arm Label

    Placebo

    Target Number of Participant

    40

    Arm Type

    Placebo comparator

    Arm Description

    For a total of 12 weeks, Once a day, 1 time a day (without water) or with water
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (N00-N99)Diseases of the genitourinary system 
       (N95.1)Menopausal and female climacteric states 
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    40Year~60Year

    Description

    1)40 to 60 year-old women with FSH 30 mIU / ml or more who have passed one year since the last menstrual period or who have no uterus
    2) Women with a kupperman index score of 20 or higher
    3) Women who have agreed to participate in this human body test before the start of the human body test and who have written an informed consent
    Exclusion Criteria
    1) Women with a body mass index (BMI) greater than 30 kg / m2
    2) Women using hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within 3 months
    3) Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast cancer or breast disease, sex hormone related cancer
    4) A woman with a history of severe migraine within the past year or who has been diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or underwent coronary angioplasty
    5) Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants
    6) Women with irregular uterine bleeding after 1 year of menopause
    7) Patients with uncontrolled hypertension (160 /100mmHg or more, After 10 minutes of stabilization)
    8) Uncontrolled diabetes mellitus patients (fasting blood sugar more than 180mg/dL or starting a new drug due to diabetes within 3 months)
    9) Patients with thyroid disease whose TSH is less than or equal to 0.1 μU / ml or more than 10 μU / ml
    10) drug or alcohol abuser
    11) If ALT or AST exceeds 3 times the normal upper limit of the research institute
    12) Creatinine exceeds twice the normal upper limit of research institute
    13) Mammography / PAP smear When a clinically significant abnormality (BI-RADS Category 0 or 3 or more, PAP smear is absent up to ASCUS) is confirmed
    14) Have participated or planned to participate in other clinical trials within the past month
    15) If the tester judges that the test is inappropriate for this human body test
    16) Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clipidogrel, etc.) within 3 months
    17) Women who took medicines or health functional foods related to women's menopause within a month
    18) Women who have taken probiotics within 2 weeks of screening
    19) Those taking or administering a therapeutic agent for osteoporosis, such as a bisphosphonate preparation
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    KMI (kupperman index, 11 items) Total point change
    Timepoint
    Visit 1, 4
    Secondary Outcome(s) 1
    Outcome
    Modified KMI's individual item scores (KMI 11 items, vaginal dry items)
    Timepoint
    Visit 1, 3, 4
    Secondary Outcome(s) 2
    Outcome
    ALP (Alkalinephosphatase)
    Timepoint
    Visit 2, 3, 4
    Secondary Outcome(s) 3
    Outcome
    Urine DPD (deoxypyridinoline)
    Timepoint
    Visit 2, 3, 4
    Secondary Outcome(s) 4
    Outcome
    Assessment of quality of life
    Timepoint
    Visit 2, 3, 4
    Secondary Outcome(s) 5
    Outcome
    Adverse reaction
    Timepoint
    Visit 3, 4
    Secondary Outcome(s) 6
    Outcome
    Clinical pathology examination
    Timepoint
    Visit 1, 4
    Secondary Outcome(s) 7
    Outcome
    Vital signs (blood pressure, pulse)
    Timepoint
    Visit 1, 3, 4
    Secondary Outcome(s) 8
    Outcome
    E2(Estradiol)
    Timepoint
    Visit 2, 4
    Secondary Outcome(s) 9
    Outcome
    Endometrial thickness
    Timepoint
    Visit 2, 4
    Secondary Outcome(s) 10
    Outcome
    OC(Osteocalcin)
    Timepoint
    Visit 2, 3, 4
    Secondary Outcome(s) 11
    Outcome
    weight
    Timepoint
    Visit 1, 3, 4
    Secondary Outcome(s) 12
    Outcome
    FSH(Follicle Stimulating Hormone)
    Timepoint
    Visit 2, 4
  • 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 No
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