UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061770 |
|---|---|
| Receipt number | R000070648 |
| Scientific Title | Exploratory Study on the Dose-Dependent Efficacy and Functional Effects of Lactic Acid Bacteria Intake for Subjects Who Experience Temporary Discomfort Associated with the Menstrual Cycle: placebo-controlled, double-blind, randomized parallel comparative test |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/05/29 12:10:00 |
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Basic information
Public title
Exploratory Study on the Dose-Dependent Efficacy and Functional Effects of Lactic Acid Bacteria Intake for Subjects Who Experience Temporary Discomfort Associated with the Menstrual Cycle
Acronym
Exploratory Study on the Dose-Dependent Efficacy and Functional Effects of Lactic Acid Bacteria Intake for Subjects Who Experience Temporary Discomfort Associated with the Menstrual Cycle
Scientific Title
Exploratory Study on the Dose-Dependent Efficacy and Functional Effects of Lactic Acid Bacteria Intake for Subjects Who Experience Temporary Discomfort Associated with the Menstrual Cycle: placebo-controlled, double-blind, randomized parallel comparative test
Scientific Title:Acronym
Exploratory Study on the Dose-Dependent Efficacy and Functional Effects of Lactic Acid Bacteria Intake for Subjects Who Experience Temporary Discomfort Associated with the Menstrual Cycle: placebo-controlled, double-blind, randomized parallel comparative test
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and functional effects of lactic acid bacteria intake in subjects who experience temporary discomfort associated with the menstrual cycle, and to determine the appropriate dose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mood Disorder Questionnaire
Premenstrual Symptoms Questionnaire
Key secondary outcomes
Profile of Mood States 2nd Edition Short Form
Clinical tests, Height and weight
Serum sex hormone parameters: estradiol and progesterone
Metabolome analysis (health claim prediction)
PMS memory
Basal body temperature
Ovulation day
Quantification of six urinary isoflavones (equol, daidzein, genistein, glycitein, daidzin, and genistin)
urinary 5 HIAA (a serotonin metabolite)
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
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake test food 1 for 4 weeks
Interventions/Control_2
Intake test food 2 for 4 weeks
Interventions/Control_3
Interventions/Control_4
Intake of the placebo food for 4 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Women aged 20 to 49 years.
(2) Subjects who experience temporary discomfort associated with the menstrual cycle.
(3) Subjects with a menstrual cycle of approximately 26 to 32 days, with a cycle variability within 6 days.
(4) Subjects who received sufficient explanation about the purpose and procedures of the study, had the capacity to provide consent, voluntarily agreed to participate after fully understanding the study, and provided written informed consent.
Key exclusion criteria
(1) Subjects with a history of diabetes, liver disease, renal disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disease, or other serious diseases.
(2) Subjects who have undergone gastrointestinal surgery.
(3) Subjects showing abnormal liver and kidney function test values.
(4) Subjects with diseases currently being treated.
(5) Subjects with food or drug allergies.
(6) Subjects with symptoms of anemia.
(7) Female subjects who wish to become pregnant during the study, or who are pregnant (including those who may be pregnant) or breastfeeding.
(8) Subjects taking hormone medication.
(9) Subjects who play intense sports or who are on a diet.
(10) Subjects with extremely irregular eating habits.
(11) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) or quasi-drugs during the study period.
(12) Subjects who are continuously undergoing treatment with pharmaceuticals (including OTC and prescription medications).
(13) Subjects who drink more than 40 g of pure alcohol per day on average.
(14) Subjects who smoke an average of 21 or more cigarettes per day.
(15) Subjects who are participating in or will participate in other clinical trials at the start of this study.
(16) Subjects who are deemed inappropriate for the study by the principal investigator or subinvestigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
5300044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6809-5220
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
LAB biotech Co., Ltd.
COSMO BIO COMPANY,LIMITED
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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6809-5220
mterashima@miura-cl.jp
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
医療法人花音会みうらクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 03 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 02 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070648
