UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061242 |
|---|---|
| Receipt number | R000070057 |
| Scientific Title | Observational study on the intestinal environment among Dstyle users |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/13 14:37:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational study on the intestinal environment among Dstyle users
Acronym
Observational study on the intestinal environment among Dstyle users
Scientific Title
Observational study on the intestinal environment among Dstyle users
Scientific Title:Acronym
Observational study on the intestinal environment among Dstyle users
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between gut microbiota and lifestyle in Japanese men and women aged 18 and older who are users of Dstyle.
Basic objectives2
Others
Basic objectives -Others
To evaluate the association between gut microbiota and lifestyle in Japanese men and women aged 18 and older who are users of Dstyle.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota, Lifestyle questionnaire (at the time of examination)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2.Japanese men and women who are Dstyle users and are 18 years of age or older at the time of consent.
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, or have a serious disease history.
2.Persons who usually take medicine or Food with Health Claims (Food for Specified Health Uses, Foods with Functional Claims, and Foods with Nutrient Function Claims) that may affect the intestinal environment.
3.Persons who have participated in other studies within one month before the start of the study, or those who intend to participate in another study after consenting to this study.
4.Persons who are pregnant, planning or hoping to be pregnant during the study period, or breastfeeding.
5.Persons who were judged as inappropriate for study participants by the principal investigator.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
BIOSIS Lab. Co., Ltd.
Division name
CEO
Zip code
470-1101
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
takumitochiobiz@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
BIOSIS Lab. Co., Ltd.
Division name
CEO
Zip code
470-1101
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
Homepage URL
takumitochiobiz@gmail.com
Sponsor or person
Institute
BIOSIS Lab. Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Dstyle Holdings Inc.
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 Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 04 | Month | 13 | 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 | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the association between gut microbiota and lifestyle in Japanese men and women aged 18 and older who are users of Dstyle.
Management information
Registered date
| 2026 | Year | 04 | Month | 13 | Day |
Last modified on
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070057
