UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062185 |
|---|---|
| Receipt number | R000071135 |
| Scientific Title | Safety Evaluation of the High-Dose Intake of Probiotics: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Study |
| Date of disclosure of the study information | 2026/07/17 |
| Last modified on | 2026/07/08 15:24:35 |
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Basic information
Public title
Safety Evaluation of the High-Dose Intake of Probiotics: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Study
Acronym
Safety Confirmation Study of the High-Dose Intake of Probiotics
Scientific Title
Safety Evaluation of the High-Dose Intake of Probiotics: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Study
Scientific Title:Acronym
Safety Confirmation Study of the High-Dose Intake of Probiotics
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of consuming high dose of the test food in healthy adults.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Adverse events
2)Side effects
3)Physical examination
4)Clinical examination
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
Intake of the test foods for 4 weeks.
Interventions/Control_2
Intake of the placebo foods 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants aged 20 to 64 years old at the time of obtaining consent.
Key exclusion criteria
1) Participants currently taking medication for any disease.
2) Participants with serious diseases (such as malignant neoplasms, respiratory diseases, hepatic, renal, cardiac, pulmonary, or gastrointestinal diseases, hematological diseases, endocrine or metabolic diseases, drug dependence, alcohol dependence, or psychiatric disorders), or history of these diseases.
3) Participants with serious drugs or food allergies.
4) Participants with serious anemia.
5) Participants who are pregnant, breastfeeding, or planning pregnancy during the study period.
6) Participants with a BMI above 30 kg/m 2.
7) Participants with excessive alcoholic drinks (average pure alcohol intake > 40 g per day for men or > 20 g per day for women).
8) Participants with a habitual heavy smoking (average of >=21 cigarettes per day).
9) Participants who have donated >=400 mL blood within 16 weeks (women), >=400 mL blood within 12 weeks (men), or >=200 mL blood within 4 weeks prior to consent.
10) Participants in or intending to join other studies involving foods, drugs, cosmetics, or topical products, or who have joined other clinical studies within four weeks before consent.
11) Participants who regularly take medications that affect the intestinal environment (such as antibiotics, intestinal regulators, constipation medications, or laxatives).
12) Participants who cannot stop consuming foods for specified health uses, functional foods, nutrient function foods, supplements, or foods containing lactic acid bacteria, bifidobacteria, or oligosaccharides during the study period.
13) Participants who engage in night work or shift work, perform physical labor, or have irregular lifestyle habits, or who may change their lifestyle during the study period.
14) Participants judged ineligible for the study by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Nakano |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Food Function Research Institute, R&D Division
Zip code
252-8583
Address
5-1-83, Higashihara, Zama city, Kanagawa, Japan
TEL
046-252-3036
kiso-hcrsmng@morinagamilk.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings 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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
jimukyoku@tes-h.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 | 07 | Month | 17 | 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 | 06 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 09 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071135
