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
CRIS Registration Number |
KCT0003211 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 2 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Korea Food Research Institute |
Organization Type | Others |
Project ID | KFRI_YT1 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Korea Food Research Institute |
Organization Type | Others |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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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 |
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Arm Description For a total of 12 weeks, Once a day, 1 time a day (without water) or with water |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (N00-N99)Diseases of the genitourinary system (N95.1)Menopausal and female climacteric states |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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 |
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Secondary Outcome(s) 5 | ||
Outcome | Adverse reaction |
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Timepoint | Visit 3, 4 |
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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 |
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Secondary Outcome(s) 9 | ||
Outcome | Endometrial thickness |
|
Timepoint | Visit 2, 4 |
|
Secondary Outcome(s) 10 | ||
Outcome | OC(Osteocalcin) |
|
Timepoint | Visit 2, 3, 4 |
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Secondary Outcome(s) 11 | ||
Outcome | weight |
|
Timepoint | Visit 1, 3, 4 |
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Secondary Outcome(s) 12 | ||
Outcome | FSH(Follicle Stimulating Hormone) |
|
Timepoint | Visit 2, 4 |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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