UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062859 |
|---|---|
| Receipt number | R000071693 |
| Scientific Title | A Study on the Effects of Continuous Intake of the Test Food on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study |
| Date of disclosure of the study information | 2026/09/09 |
| Last modified on | 2026/09/09 15:48:06 |
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Basic information
Public title
A Study on the Effects of Continuous Intake of the Test Food on Immune Function
Acronym
A Study on the Effects of Continuous Intake of the Test Food on Immune Function
Scientific Title
A Study on the Effects of Continuous Intake of the Test Food on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Scientific Title:Acronym
A Study on the Effects of Continuous Intake of the Test Food on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 12-week continuous intake of the test food on immune function in healthy individuals who subjectively feel susceptible to catching colds through a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
pDC
Key secondary outcomes
(1) Cumulative days of common cold symptoms
(2) Maximum duration of common cold symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food group: Tablets containing lactic acid bacteria (1 tablet daily for 12 weeks)
Interventions/Control_2
Placebo group: Placebo tablets (1 tablet daily 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese male and female subjects aged 20 to 64 years at the time of providing informed consent.
(2) Participants who subjectively feel that they easily catch colds in daily life.
(3) Participants with relatively low salivary sIgA levels at the visit screening test.
(4) Participants who have received a thorough explanation of the purpose and content of the trial, possess the capacity to consent, fully understand the content, and can provide personal consent via electronic informed consent.
Key exclusion criteria
(1) Participants receiving medical treatment/medication for autoimmune/immunodeficiency diseases or allergic diseases, or planning to during the study.
(2) Participants regularly using immunosuppressants, steroids, antiallergics, antihistamines, or intestinal regulators.
(3) Participants with chronic diseases (e.g., diabetes, dyslipidemia, hypertension) receiving treatment/medication.
(4) Participants with a history of serious cerebrovascular, cardiac, hepatic, renal, hematological, or endocrine diseases.
(5) Participants with a history of serious gastrointestinal diseases (e.g., gastrectomy, bowel resection; excluding appendectomy).
(6) Participants at risk of allergic reactions to the test foods.
(7) Participants with significant abnormalities in screening tests (vital signs, physical examinations, or blood tests).
(8) Participants who experienced feeling unwell during past blood sampling.
(9) Participants who donated 200 mL blood within 4 weeks or component blood within 2 weeks; females who donated 400 mL within 16 weeks; males who donated 400 mL within 12 weeks.
(10) Participants who may develop pollinosis during the study period (Dec-Mar).
(11) Participants vaccinated within 4 weeks prior to screening, or unable to agree not to receive vaccines during the study.
(12) Participants with oral diseases with bleeding tendency that may contaminate saliva.
(13) Participants unable to stop intake of FOSHU, Foods with Function Claims, or supplements.
(14) Current smokers.
(15) Regular alcohol drinkers (approx. 60 g/day or more).
(16) Participants with extremely irregular sleep or dietary habits.
(17) Participants whose living environment, dietary, or exercise habits may change significantly.
(18) Pregnant, lactating, or planning to become pregnant females.
(19) Participants who are participating, have participated within the past 4 weeks, or are planning to participate in other clinical trials.
(20) Participants judged ineligible by the principal investigator.
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
umin_info@macromillcarenet.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Kimoto |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
Homepage URL
umin_info@macromillcarenet.jp
Sponsor or person
Institute
Macromill Carenet, Inc.
Institute
Department
Personal name
Funding Source
Organization
ICHIBIKI 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
Institutional Review Board (IRB) of Tokyo Haneda Watanabe Clinic
Address
1-6-15 Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
wnb.cto@gmail.com
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
医療法人社団 糺榮会 東京羽田渡辺クリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 09 | 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 | 09 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 23 | 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 | 09 | Month | 09 | Day |
Last modified on
| 2026 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071693
