UMIN-CTR Clinical Trial

Basic information
Public title	Examination study of the effect of lactic acid bacteria on the imbalance and discomfort of mental and physical conditions in healthy peri/post-menopause females
Acronym	Examination study of the effect of lactic acid bacteria on the imbalance and discomfort of mental and physical conditions in healthy peri/post-menopause females
Scientific Title	A randomized, placebo-controlled, double blind, parallel study of the effect of lactic acid bacteria on the imbalance and discomfort of mental and physical conditions in healthy peri/post-menopause females
Scientific Title:Acronym	A randomized, placebo-controlled, double blind, parallel study of the effect of lactic acid bacteria on the imbalance and discomfort of mental and physical conditions in healthy peri/post-menopause females
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to investigate the effects of continuation intake of test food for 12 weeks on the imbalance and discomfort of mental and physical condition in healthy Japanese peri/post-menopause females who aged order 45 years or less than 55 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Kupperman's menopausal index
Key secondary outcomes	Izumo scale SF-8 Japanese version Questionnaire for skin condition FSH Estrone Estradiol Defecation frequency Volume of stool Property of stool Enzymatic activity of stool

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Take 1 capsule of the test food for 12 weeks.
Interventions/Control_2	Take 1 capsule of the placebo food for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	45 years-old <=
Age-upper limit	54 years-old >=
Gender	Female
Key inclusion criteria	1) Japanese female aged older 45 years or and less than 55 years at the time of the informed consent 2) Subjects who feels their menstrual cycle, amount of menstrual blood, menstrual period, and degree of abdominal pain before and during menstruation have changed compared to those in their 20s (including menopause) 3) Subjects who feel menopausal symptoms (hot flashes, sweating) within the range that does not interfere with daily life 4) Subjects who are not suffering from serious diseases 5) Subjects who can enter examinations and records by visiting the hospital on a specified date 6) Subjects who have understood the purpose of the study and agreed to participate it by signing the written informed consent
Key exclusion criteria	1) Subjects who are suffering from or treated for diseases that affect menopausal symptoms, including thyroid and psychological disorders 2) Subjects who are suffering from menopausal symptoms due to surgical procedures such as oophorectomy 3) Subjects who are judged by the principal investigator to require treatment such as medication for menopausal symptoms 4) Subjects who had a history of menopausal disorders 5) Subjects who regularly use pharmaceuticals, Food for Specified Health Uses, Foods with Functional Claims, health food, and supplements that affect this study 6) Subjects who have an allergy for the pharmaceuticals and foods that affect this study 7) Subjects who have hypersensitivity reactions for test foods 8) Subjects who drink more than 20 grams of alcohol per day 9) Subjects who smoke more than 20 cigarettes per day 10) Subjects who are unable to refrain from consuming Food for Specified Health Uses, Foods with Functional Claims, and other so-called health foods during the study 11) Subjects who have been participated in other clinical trial or trials, or wish to participate within the study period 12) Subjects who are unable to follow the doctor's instructions or are judged as an inappropriate candidate by the doctor
Target sample size	106

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ueda
Organization	KANEKA CORPORATION
Division name	Pharma & Supplemental Nutrition Solutions Vehicle
Zip code	1076025
Address	1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL	03-3133-7349
Email	Takahiro.Ueda@kaneka.co.jp

Public contact
Name of contact person	1st name Soichi Middle name Last name Yoneda
Organization	Mibyou Life Science inc
Division name	Clinical Trials Division
Zip code	1010061
Address	2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
TEL	03-6256-9600
Homepage URL
Email	renraku@mibyou-ls.com

Sponsor
Institute	Mibyou Life Science inc
Institute
Department

Funding Source
Organization	Kaneka Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mibyou Research Ethics Review Committee
Address	2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
Tel	03-6272-9163
Email	renraku@npo-mibyou.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団菱秀会 金内メディカルクリニック（東京都） 医療法人社団恒新会 武蔵境クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	115
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 09 Month 09 Day
Date of IRB	2021 Year 09 Month 17 Day
Anticipated trial start date	2021 Year 09 Month 24 Day
Last follow-up date	2022 Year 02 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 22 Day
Last modified on	2022 Year 05 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052003