UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060983 |
|---|---|
| Receipt number | R000069740 |
| Scientific Title | A study on changes in antiviral immune responses induced by lactic acid bacteria intake: A randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/18 11:40:37 |
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Basic information
Public title
A study on changes in antiviral immune responses induced by lactic acid bacteria intake: A randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
A study on changes in antiviral immune responses induced by lactic acid bacteria intake
Scientific Title
A study on changes in antiviral immune responses induced by lactic acid bacteria intake: A randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
A study on changes in antiviral immune responses induced by lactic acid bacteria intake
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of study food intake on immune responses
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antiviral immune cell parameters
Key secondary outcomes
Cytokines
Antiviral gene expression
Cold-like symptoms questionnaire
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
8-week daily intake of lactic acid bacteria
Interventions/Control_2
8-week daily intake of placebo (not containing lactic acid bacteria)
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 males and females from 20 to 64 years old.
2) Individuals who self-identify as being susceptible to colds or influenza.
3) Individuals who received sufficient explanation of the purpose and details of the study, have the capacity to provide consent, fully understood the information, voluntarily agreed to participate, and provided written informed consent.
Key exclusion criteria
1) Individuals with severe diseases such as diabetes, renal or hepatic disorders, cardiac diseases, thyroid disorders, adrenal disorders, psychiatric disorders, autoimmune diseases, or other metabolic diseases, or those currently undergoing treatment for these conditions (except for individuals deemed eligible by the principal investigator).
2) Individuals with chronic diseases who routinely take medication.
3) Individuals with atopic dermatitis, bronchial asthma, or chronic bronchitis.
4) Individuals who are unable to refrain from consuming foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, or live microorganisms during the study period.
5) Individuals who plan to regularly visit a clinic or use prescription medications each year due to hay fever or allergic rhinitis.
6) Individuals with a history or current diagnosis of drug dependence or alcohol dependence.
7) Individuals with gastrointestinal diseases or a history of gastrointestinal surgery that may affect digestion or absorption (appendectomy excluded).
8) Individuals who are unable to discontinue supplements or health foods (including Foods for Specified Health Uses and Foods with Functional Claims) during the study period.
9) Individuals who are habitual smokers.
10) Individuals with extremely irregular dietary habits (e.g., one meal per day or insufficient nutritional intake).
11) Individuals with excessive alcohol consumption, defined as more than approximately 60 g of pure alcohol per day.
12) Individuals who are unable to abstain from alcohol for two days prior to the screening and each subsequent test visit.
13) Individuals who report having food allergies to any components of the study product.
14) Individuals engaged in shift work, night work, or physically demanding labor such as heavy lifting.
15) Individuals who go out less than twice a week.
Due to character limitations, part of the exclusion criteria is presented in the 'Other Related Information' section.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuge |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi,Maebashi-shi,Gumma
Tel
027-212-5608
sagawa@mc-connect.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 | 03 | Month | 20 | 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 | 01 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Additional exclusion criteria that could not be included in the main section due to character limitations are provided below.
16) Pregnant individuals, individuals planning to become pregnant during the study period, or individuals who are breastfeeding.
17) Individuals judged as unsuitable for participation based on blood tests or other screening assessments.
18) Individuals who are scheduled to receive vaccinations for infectious diseases during the study period.
19) Individuals who plan to travel abroad during the study period.
20) Individuals who have taken antibiotics within one month prior to the screening test.
21) Individuals who have donated more than 200 mL of blood within the past month or more than 400 mL within the past three months, or have undergone component donation during the same period.
22) Individuals who are currently participating in another study involving food intake, medication use, or topical application of cosmetics, or who plan to participate in such a study.
23) Any other individuals judged as unsuitable for participation by the principal investigator.
Management information
Registered date
| 2026 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069740
