UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055175 |
|---|---|
| Receipt number | R000063041 |
| Scientific Title | Effects of Continuous Ingestion of Bifidobacteria on Women's Health: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study. |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2025/10/02 12:56:28 |
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Basic information
Public title
Effects of Continuous Ingestion of Bifidobacteria on Women's Health:A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Acronym
Effects of Continuous Ingestion of Bifidobacteria on Women's Health
Scientific Title
Effects of Continuous Ingestion of Bifidobacteria on Women's Health: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Scientific Title:Acronym
Effects of Continuous Ingestion of Bifidobacteria on Women's Health
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous ingestion of Bifidobacteria on premenstrual mood states.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
menstrual distress questionnaire(MDQ)
Key secondary outcomes
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test powder containing Bifidobacteria for a duration of 3 menstrual cycles.
Interventions/Control_2
Intake of placebo powder for a duration of 3 menstrual cycles.
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
| 25 | years-old | <= |
Age-upper limit
| 34 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Individuals aged between 25 and 34 years
(2)ndividuals with a menstrual cycle of 25 to 38 days and a menstrual duration of 3 to 7 days
Key exclusion criteria
(1)Individuals who have or have a history of gynecological diseases (such as menorrhagia, secondary amenorrhea, breast cancer, endometriosis, uterine fibroids, endometrial cancer, cervical cancer, uterine body cancer, ovarian cancer, etc.)
(2)Individuals who have suspected or have a history of mood disorders (such as clinical depression, premenstrual dysphoric disorder(PMDD), etc.)
(3)Individuals who frequently use medications (including low-dose pills and herbal medicines)or quasi-drugs that are considered to have a significant impact on physical and mental symptoms related to menstruation
(4)Individuals who cannot stop consuming specific health foods, functional foods, supplements, or foods (including specific Bifidobacteria or lactic acid bacteria)that are considered to affect physical and mental symptoms after registration
(5)Heavy smokers
(6)Heavy drinkers (60g or more of pure alcohol per day)
(7)Individuals with disrupted lifestyles
(8)Individuals who have or have a history of serious diseases, such as malignant tumors, respiratory diseases, liver, kidney, heart, lung, gastrointestinal, blood, endocrine, and metabolic disorders
(9)Individuals who have or have a history of severe drug or food allergy
(10)Individuals who are pregnant, intend to become pregnant during the trial period, or are breastfeeding
(11)Individuals with a BMI of less than 18.5 kg/m 2 or 30 kg/m 2 or more
(12)Individuals who are participating or plan to participate in other clinical trials for 4 weeks before the pre-examination to the end of the intake period
(13)Individuals who are ineligible based on the principal investigator's judgment.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Life Science Division Clinical Research Unit
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Sugioka |
Organization
Macromill, Inc.
Division name
Life Science Division Clinical Research Unit
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
Homepage URL
sugioka@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Institutional review board of Tsukiji Futaba Clinic
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo, Japan, 104-0045
Tel
03-6226-5812
tohru@hikobae.net
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
株式会社 マクロミル（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 06 | 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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063041
