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

Not Applicable

Completed

• Conditions: Symptoms, signs and abnormal clinical and laboratory findings, NEC

• Registration Number: KCT0003211
• Lead Sponsor: Korea Food Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KMI (kupperman index, 11 items) Total point change

Secondary Outcome Measures

Name	Time	Method
Modified KMI's individual item scores (KMI 11 items, vaginal dry items);ALP (Alkalinephosphatase);Urine DPD (deoxypyridinoline);Assessment of quality of life;Adverse reaction;Clinical pathology examination;Vital signs (blood pressure, pulse);E2(Estradiol);Endometrial thickness;OC(Osteocalcin);weight;FSH(Follicle Stimulating Hormone)