UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052818 |
|---|---|
| Receipt number | R000060282 |
| Scientific Title | A study to confirm the effect of lactic acid bacteria intake on improving immune function - Randomized, double-blind, placebo-controlled, parallel-group comparison study - |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2024/01/29 15:06:40 |
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Basic information
Public title
A study to confirm the effect of lactic acid bacteria intake on improving immune function - Randomized, double-blind, placebo-controlled, parallel-group comparison study -
Acronym
A study to confirm the effect of lactic acid bacteria intake on improving immune function
Scientific Title
A study to confirm the effect of lactic acid bacteria intake on improving immune function - Randomized, double-blind, placebo-controlled, parallel-group comparison study -
Scientific Title:Acronym
A study to confirm the effect of lactic acid bacteria intake on improving immune function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of the study food intake on immune functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cold-like symptoms questionnaire
Key secondary outcomes
mDC activity, salivary sIgA, NK cell activity, CD8+T cell activity, CD4+T cell activity, B cell activity
intestinal condition questionnaire, SF-36, stress and other things measured by visual analog scale (VAS), OSA sleep inventory MA version (OSA-MA)
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
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
8-week intake of low dose lactic acid bacteria
Interventions/Control_2
8-week intake of high dose lactic acid bacteria
Interventions/Control_3
8-week intake of placebo (not containing lactic acid bacteria)
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 65 years old.
2) Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the study, and have agreed to participate in the study in writing.
Key exclusion criteria
Subjects--
1) suffering from, undergoing treatment, or with a history of diabetes, renal or hepatic disease, or other serious illness, thyroid disease, adrenal gland disease, psychiatric disease, autoimmune disease, or other metabolic disease.
2) who cannot stop taking foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, or other viable bacteria during the study period.
3) who regularly use foods that may affect immunity.
4) who constantly consumes more than the appropriate amount of alcohol.
5) who are unable to abstain from alcohol for 2 days prior to each test.
6) who have declared having food allergies.
7) with a history of gastrointestinal diseases or gastrointestinal surgery (except appendicitis).
8) who are pregnant, breast feeding, or planning to be pregnant during the study period.
9) with a history or current history of drug or alcohol dependence.
10) who are participating or intend to participate in other studies involving the use of other foods, drugs or cosmetics.
11) who regularly use medicines that may affect immunity, or who are unable to stop taking them during the study period.
12) with hay fever, atopic dermatitis, allergic rhinitis, bronchial asthma, or chronic bronchitis.
13) who plan to visit the hospital or take/use prescription medication annually due to hay fever or allergic rhinitis.
14) who have oral problems that involve bleeding, or plan to undergo dental or oral treatment.
15) who engage in strenuous exercise.
16) who plan to travel abroad during the study period.
17) who have taken antibiotics within 1 month of the screening test.
18) who smoke.
19) who are diagnosed as anemic by screening tests and are not suitable for blood sampling.
20) who have donated blood drawn or component blood more than 200 mL within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
21) who work in day and night shifts, late at night, or who are full telecommuters or blue-collar workers.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
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
eigyou@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 Joto-machi, Maebashi-shi, Gunma
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
| 2025 | Year | 06 | Month | 30 | 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
| 2023 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060282
