UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062801 |
|---|---|
| Receipt number | R000071891 |
| Scientific Title | Comparative study between site-visiting and remote trials |
| Date of disclosure of the study information | 2026/09/04 |
| Last modified on | 2026/09/03 11:41:09 |
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Basic information
Public title
Comparative study between site-visiting and remote trials
Acronym
Comparative study between site-visiting and remote trials
Scientific Title
Comparative study between site-visiting and remote trials
Scientific Title:Acronym
Comparative study between site-visiting and remote trials
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the changes in the intestinal environment and compliance with instructions during the trial period between site-visiting and remote trials when bifidobacteria supplements are ingested daily for 4 weeks by adults aged 18 to under 65 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trial completion rate, diary completion rate, test food intake rate, and lifestyle during the study period during or after the study period.
Key secondary outcomes
Intestinal environment (urinary indoxyl sulfate, urinary creatinine), oxidative stress level (urinary 8-OHdG, urinary creatinine), protein test (urinary urea nitrogen, urinary creatinine), defecation questionnaire, questionnaire regarding physical condition, and subjective findings (lifestyle diary, etc.) at the beginning of or after the intake for 4 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
(site-visiting)Intake 2 capsules (once a day) of the test food daily for 4 weeks.
Interventions/Control_2
(remote trials)Intake 2 capsules (once a day) of the test food daily for 4 weeks.
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
| 65 | years-old | > |
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 persons who are 18 years old or more and under 65 years old at the time of obtaining consent.
Key exclusion criteria
1. Persons who have chronic illness, receiving medication, or have a serious disease history.
2. Persons who are allergic to the test food.
3. Persons who usually take a large amount of test food.
4. Persons who usually take medicine or functional foods for health uses (specified health foods, functional foods, and functional nutrition foods) that may affect the intestinal environment and antioxidant activity.
5. Persons who have participated in other studies within 1 month before the start of the study, or who intend to participate in another study after consenting to this study.
6. Persons who were judged as inappropriate for study participants by the principal investigator or trial supervising physician.
7. Persons who are pregnant, planning or hoping to be pregnant during the study period, or breastfeeding.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
ishikawa@hc-sys.jp
Public contact
Name of contact person
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
rinsho@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Healthcare Systems 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 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 | 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
| 2026 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 01 | 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 | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071891
