UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062348 |
|---|---|
| Receipt number | R000071355 |
| Scientific Title | Safety evaluation of long-term intake of food containing bifidobacterium in healthy adults. |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/07/27 12:46:52 |
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Basic information
Public title
Safety evaluation of long-term intake of food containing bifidobacterium in healthy adults.
Acronym
Safety evaluation of long-term intake of food containing bifidobacterium in healthy adults.
Scientific Title
Safety evaluation of long-term intake of food containing bifidobacterium in healthy adults.
Scientific Title:Acronym
Safety evaluation of long-term intake of food containing bifidobacterium in healthy adults.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of consuming a food containing bifidobacterium at the recommended daily intake for 12 consecutive weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematological examinations, blood biochemical examinations, urinalysis, blood pressure and pulse rate measurements, body weight and BMI measurements, physician interviews, and assessment of adverse events will be conducted before consumption of the test food and at Weeks 4, 8, and 12 during the intervention period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of food containing bifidobacterium at the recommended daily intake for 12 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male and female participants aged >=18 and <65 years.
(2) Participants who, after fully understanding the purpose and content of the study, voluntarily consent to participate in the study of their own free will.
Key exclusion criteria
(1) Participants who regularly consume foods containing high levels of the study-related component.
(2) Participants who have previously shown abnormalities in clinical laboratory values or cardiopulmonary function and are judged by the principal investigator to be unsuitable for participation in the study.
(3) Participants who are at risk of developing allergic reactions related to the study.
(4) Participants who have diseases requiring continuous medication, are currently undergoing treatment (excluding dry eye and dental caries treatment), or have a history of serious diseases requiring pharmacological treatment.
(5) Participants whose pre-intake clinical laboratory values or measurement results show markedly abnormal values outside the reference range.
(6) Participants with irregular lifestyles, such as shift workers or those engaged in night work.
(7) Participants who have participated in other clinical studies, clinical trials, or human studies within one month prior to the start of this study.
(8) Participants who are pregnant, or planning to become pregnant or breastfeed during the study period.
(9) Participants who are judged to be unsuitable as study participants based on responses to the lifestyle questionnaire.
(10) Participants who are otherwise judged by the principal investigator to be unsuitable for participation in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Uenishi |
Organization
MEGMILK SNOW BRAND Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2, Minamidai, Kawagoe-shi, Saitama, 350-1165, Japan
TEL
049-242-8150
h-uenishi@meg-snow.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo,
TEL
090-4821-1099
Homepage URL
yamamichi.shingo578@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 25 | 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 | 07 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 23 | 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 | 27 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071355
