UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062157 |
|---|---|
| Receipt number | R000071049 |
| Scientific Title | A Comprehensive Study of Changes in Gut Microbiota and Mental and Physical Health Status Following Lifestyle Guidance and Exercise Intervention |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/11 01:14:08 |
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Basic information
Public title
A Comprehensive Study of Gut Microbiota and Mental and Physical Health Following Lifestyle Guidance and Exercise Intervention
Acronym
BTC25C1
Scientific Title
A Comprehensive Study of Changes in Gut Microbiota and Mental and Physical Health Status Following Lifestyle Guidance and Exercise Intervention
Scientific Title:Acronym
BTC25C1
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of lifestyle guidance on gut microbiota composition in healthy adults, and to explore the association between changes in gut microbiota and brain measures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota analysis (Changes between week 0 and week 8 of intervention)
Key secondary outcomes
Subjective questionnaires (depressive mood, physical activity, sleep quality, skin condition, bowel condition, lifestyle, well-being), dietary survey, and brain imaging measures (BHQ: grey-matter volume and white-matter FA) [change from 0 to 8 weeks]; simplified brain health estimation (Quick BHQ Dock) [assessed every 2 weeks]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: 8-week dietitian-led lifestyle guidance and a mental health seminar.
Interventions/Control_2
Wearing a digital device (Fitbit or MITSUFUJI03) at all times except during bathing to record ambient temperature, step count, heart rate, and pulse wave. Sending a notification every Monday to promote walking "7,000 steps or more per day". The intervention period is 8 weeks.
Interventions/Control_3
No specific intervention (No-treatment control)
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 18 to under 80 years at the time of consent. 2. Those who have received sufficient explanation about the study, understand its contents, and can provide personal consent.
Key exclusion criteria
1. Those participating in other clinical trials for pharmaceuticals or health foods within 4 weeks. 2. Others judged inappropriate for participation in this study by the principal investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Natsuki |
| Middle name | |
| Last name | Suganuma |
Organization
bacterico, Inc.
Division name
Research and Development Department
Zip code
530-0027
Address
7th Floor, Sankyo Umeda Building, 1-5 Douyamacho, Kita-ku, Osaka City, Osaka Prefecture
TEL
06-4397-3516
info@bacterico.co.jp
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Suganuma |
Organization
bacterico, Inc.
Division name
Research and Development Department
Zip code
530-0027
Address
7th Floor, Sankyo Umeda Building, 1-5 Douyamacho, Kita-ku, Osaka City, Osaka Prefecture
TEL
06-4397-3516
Homepage URL
info@bacterico.co.jp
Sponsor or person
Institute
bacterico, Inc.
Institute
Department
Personal name
Funding Source
Organization
PwC Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiyoda Paramedical Care Clinic Ethics Committee
Address
2nd Floor, Daiwa Building, 3-3-10 Nihonbashi Honcho, Chuo-ku, Tokyo
Tel
03-6225-9005
IRB@cpcc.co.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | 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
91
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
| 2025 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 03 | 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 | 07 | Month | 07 | Day |
Last modified on
| 2026 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071049
