UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058991 |
|---|---|
| Receipt number | R000066839 |
| Scientific Title | Evaluation of the effects of probiotic intake on symptoms of male menopause: a double-blind, randomized, parallel-group controlled trial |
| Date of disclosure of the study information | 2025/09/04 |
| Last modified on | 2025/09/04 14:37:35 |
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Basic information
Public title
Evaluation of the effects of probiotic intake on symptoms of male menopause: a double-blind, randomized, parallel-group controlled trial
Acronym
Evaluation of the effects of probiotic intake on symptoms of male menopause: a double-blind, randomized, parallel-group controlled trial
Scientific Title
Evaluation of the effects of probiotic intake on symptoms of male menopause: a double-blind, randomized, parallel-group controlled trial
Scientific Title:Acronym
Evaluation of the effects of probiotic intake on symptoms of male menopause: a double-blind, randomized, parallel-group controlled trial
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Focusing on the probiotic effects of Limosilactobacillus (L.) reuteri ATCC PTA 6475, this double-blind, randomized, parallel-group controlled trial aims to observe how the characteristic conditions associated with male menopause change following its intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline (week 0) over 12 weeks in the Heinemann Aging Males' Symptoms (AMS) score
Key secondary outcomes
12-week changes in serum testosterone levels (total and free), estradiol levels, SF-36 (Medical Outcome Study 36-Item Short-Form Health Survey; a questionnaire for assessing health-related quality of life), muscle mass, and fecal microbiota.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Capsules containing freeze-dried L. reuteri ATCC PTA 6475 powder, formulated to provide 5x10^9 CFU per capsule. Participants will take 8 capsules per day.
Interventions/Control_2
Capsules manufactured by replacing the freeze-dried L. reuteri ATCC PTA 6475 powder with maltodextrin, so that they contain no bacterial powder. Participants will take 8 capsules per day.
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy male
2) Willing to provide written informed consent
Key exclusion criteria
1) Individuals who regularly take medication for chronic diseases
2) Individuals suspected of having a disease at the time of the screening test
3) Individuals who experience early morning erections less than once per week on average
4) Individuals with a total AMS score indicating severe symptoms (50 points or higher)
5) Individuals who regularly take supplements (including foods) that may affect sex hormone levels or gut microbiota
6) Individuals currently undergoing treatment for, or with a history of, erectile dysfunction (ED) or benign prostatic hyperplasia
7) Individuals with a history of mental disorders such as depression or attention-deficit/hyperactivity disorder (ADHD)
8) Individuals participating in another clinical study at the time of this study or who have participated in another clinical study within the past three months
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Noda |
Organization
Graduate School of Biomedical and Health Scie nces, Hiroshima University
Division name
Department of Probiotic Science for Preventive Medicine
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-1533
bel@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Noda |
Organization
Graduate School of Biomedical and Health Scie nces, Hiroshima University
Division name
Department of Probiotic Science for Preventive Medicine
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-1533
Homepage URL
funcfood@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
BioGaia AB
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 04 | 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 | 07 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066839
