UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061167 |
|---|---|
| Receipt number | R000069898 |
| Scientific Title | Safety Evaluation of Long-term Intake of a Probiotic food: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study |
| Date of disclosure of the study information | 2026/04/06 |
| Last modified on | 2026/04/03 20:23:15 |
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Basic information
Public title
Safety Evaluation of Long-term Intake of a Probiotic food: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Acronym
Safety Evaluation of Long-term Intake of a Probiotic food
Scientific Title
Safety Evaluation of Long-term Intake of a Probiotic food: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Scientific Title:Acronym
Safety Evaluation of Long-term Intake of a Probiotic food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of 12-week intake of a probiotic food in healthy adults
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events, side effects, physical examinations (body measurements, blood pressure, pulse), clinical tests (hematology, biochemistry, urinalysis), and physician interviews
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will take one sachet of the test food daily with water for 12 weeks.
Interventions/Control_2
Participants will take one sachet of the placebo food daily with water for 12 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. Aged 18 to under 65 at consent.
2. Able to enter study diary via smartphone or PC.
3. Fully informed of the study purpose and research content, able to consent, and voluntarily agreed in writing to participate.
Key exclusion criteria
1. History or presence of serious diseases: malignancy, respiratory, hepatic, renal, cardiac, pulmonary, gastrointestinal (including history of surgery affecting digestion/absorption), hematologic, endocrine, metabolic disorders, drug/alcohol dependence, psychiatric disorders.
2. Currently receiving treatment for any disease with medication or Kampo (as-needed drugs excluded).
3. BMI >=30.0 kg/m^2.
4. History or presence of drug or food allergies.
5. Severe anemia.
6. History of adverse reactions to blood sampling, vasovagal response, or difficulty with blood draws.
7. Pregnant, planning pregnancy during the study, or breastfeeding.
8. Heavy smokers (>=21 cigarettes/day).
9. Average daily alcohol intake >40 g (pure alcohol).
10. Unable to discontinue over-the-counter drugs, quasi-drugs, foods with health claims, or supplements during the study.
11. Scheduled for endoscopy, barium study, H. pylori eradication, or tooth extraction during the study.
12. Scheduled for vaccination during the study.
13. Women who donated >=400 mL blood within 16 weeks, men within 12 weeks, or anyone who donated >=200 mL within 4 weeks prior to consent.
14. Night shift/rotating workers, manual laborers, or those with irregular lifestyles, or likely to change lifestyle during the study.
15. Receiving physician-supervised exercise, dietary, or health guidance.
16. Participating in other studies involving food, drugs, cosmetics, or had participated in another clinical study within 4 weeks before consent.
17. Deemed unsuitable by the principal investigator based on background, physical findings, interview, vital signs, or lab results.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Higashi Koganei Sakura Clinic
Division name
Hospital Director
Zip code
184-0011
Address
4-37-26, Higashicho, Koganei-shi, Tokyo, Japan
TEL
042-382-3888
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1, Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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 | 04 | Month | 06 | 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 | 02 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069898
