UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057720 |
|---|---|
| Receipt number | R000065953 |
| Scientific Title | Efficacy and functionality exploratory study of lactic acid bacteria intake for premenstrual syndrome (PMS)- Open label test - |
| Date of disclosure of the study information | 2025/04/25 |
| Last modified on | 2025/04/25 17:03:30 |
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Basic information
Public title
Efficacy and functionality exploratory study of lactic acid bacteria intake for premenstrual syndrome (PMS)
Acronym
Efficacy and functionality exploratory study of lactic acid bacteria intake for premenstrual syndrome (PMS)
Scientific Title
Efficacy and functionality exploratory study of lactic acid bacteria intake for premenstrual syndrome (PMS)- Open label test -
Scientific Title:Acronym
Efficacy and functionality exploratory study of lactic acid bacteria intake for premenstrual syndrome (PMS)- Open label test -
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the impact of test food intake on premenstrual syndrome.
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
OSA sleep inventory MA version
Profile of Mood States 2nd Edition Short Form
Clinical tests (hematological tests, blood biochemistry tests 1, urinalysis)
Height, weight, physical examination
Blood hormone items (estrogen, progesterone)
Metabolome analysis
PMS memory
Basal body temperature
Ovulation day
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake test food for 4 weeks
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Women aged 20 to 49 years old.
(2) Subjects with premenstrual syndrome (PMS) symptoms.
(3) Subjects with a menstrual cycle of approximately 26 to 32 days, and cycle variability within plus or minus days.
(4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing
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 disease
(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 and drug allergies
(6) Subjects with symptoms of anemia.
(7) Female subjects who wish to become pregnant while participating in this study, female subjects who are pregnant (including those who may be pregnant) or who are breastfeeding
(8) Subjects taking hormone medication.
(9) Subjects who play intense sports and subjects 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) and quasi-drugs during the test period
(12) Subjects who are continuously undergoing treatment with pharmaceuticals (including OTC and prescription medications).
(13) Subjects who drink more than 40g of average daily pure alcohol
(14) Subjects who smoke an average of 21 or more cigarettes a day
(15) Subjects who are participating in or will participate in other clinical trials at the start of this study
(16) Subjects who are otherwise deemed inappropriate for the study by the principal investigator or subinvestigator
Target sample size
12
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 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6135-5200
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
LABbiotech Co., Ltd.
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 Commiittee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
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
| 2025 | Year | 04 | Month | 25 | 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
| 2025 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2025 | Year | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065953
