UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060269 |
|---|---|
| Receipt number | R000068932 |
| Scientific Title | Immune Function Evaluation Test for Levilactobacillus brevis subsp. coagulans FERM BP-4693 (Labre) |
| Date of disclosure of the study information | 2026/01/15 |
| Last modified on | 2026/01/05 18:07:06 |
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Basic information
Public title
Immune Function Evaluation Test for Levilactobacillus brevis subsp. coagulans FERM BP-4693 (Labre)
Acronym
Immune Function Evaluation Test for Levilactobacillus brevis subsp. coagulans FERM BP-4693 (Labre)
Scientific Title
Immune Function Evaluation Test for Levilactobacillus brevis subsp. coagulans FERM BP-4693 (Labre)
Scientific Title:Acronym
Immune Function Evaluation Test for Levilactobacillus brevis subsp. coagulans FERM BP-4693 (Labre)
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary endpoint will be the intergroup difference in the cumulative number of Good Health Days (GHD) during the intervention period in adults aged 20 to 79 years who consumed Lactobacillus brevis-containing food for 12 weeks. Secondary endpoints include symptom duration, blood cytokines, immune phenotypes assessed by CyTOF/multicolor flow cytometry, and quality of life (QOL).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative Days of GHD (Good Health Days) During the 12-Week Intervention
Cumulative Days
1) Definition of GHD: Counted as GHD=1 when the daily self-rated health status in the eDiary is "0 (Very Good)" or "1 (Good)" and none of the following symptoms (malaise, chills, fever, fatigue, headache, runny nose, nasal congestion, sneezing, cough, sore throat, joint pain, muscle pain) are present.
2) Calculation: Cumulative GHD days over 12 weeks of intervention. Cumulative GHD during the 7-day run-in period is included as a covariate in the statistical model.
3) Recording Quality/Missing Data: Weekly recording rate <80% is considered a potential outlier. The primary analysis uses multiple imputation (MAR) for missing data, with best-case and worst-case sensitivity analyses performed.
Key secondary outcomes
1. Duration of Symptoms: Number of days experiencing systemic symptoms (malaise, chills, fever, fatigue) and local symptoms (headache, runny nose, nasal congestion, sneezing, cough, sore throat, joint pain, muscle pain)
2. Primary and Secondary Immunological Parameters (Pre-selected, up to 5 items): 1) IFN-gamma concentration, 2) IL-6 concentration, 3) XCL10 (IP-10) concentration, 4) CD4+ Treg ratio, 5) CD8+ TEMRA ratio
3. Exploratory Immune Parameters: Blood cytokines (comprehensive panel including FLT3LG, CSF3, VEGFA), CyTOF or multicolor flow cytometry for T B NK gamma-delta T monocyte DC granulocyte subsets and activity or senescence markers (CD28, CD57, CD38, HLA-DR, etc.)
4. QOL or Fatigue: Fatigue VAS, Dartmouth COOP, SF-36
5. Mucosal immunity: Upper respiratory symptom diary
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
Lactobacillus reuteri: Capsules containing 100 billion CFU (colony-forming units) of Lactobacillus reuteri per day
Interventions/Control_2
Placebo group: Capsules identical in appearance and taste but not containing Lactobacillus brevis
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals who have obtained consent in writing or by electronic means
2. Japanese adult men and women aged 20 to 79 at the time consent was obtained
Key exclusion criteria
1. Individuals with immunosuppression or chronic diseases
2. Individuals currently taking immunosuppressants, anti-inflammatory drugs, or antibacterial drugs
3. Individuals who habitually use excessive amounts of moisturizers or laxatives in daily life
4. Individuals who habitually consume specific lactic acid bacteria preparations or supplements in daily life
5. Individuals who are pregnant or breastfeeding, or who plan/intend to become pregnant during the study period
6. Individuals with allergies to standard foods/test foods
7. Individuals unable to refrain from receiving new vaccinations (seasonal influenza/COVID-19) during the study period after consent is obtained
8. Individuals unable to complete each questionnaire according to the schedule
9. Individuals with a history of overseas travel within 2 weeks prior to the consent date or planning overseas travel during the study period
10. Individuals without a smartphone
11. Individuals who participated in another study within one month prior to study initiation, or who plan to participate in another study after providing consent for this study
12. Individuals deemed ineligible by the physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Sakurai |
Organization
Clinical Creative Corporation
Division name
Pharmaceuticals Division
Zip code
353-0001
Address
4-1-37 Kamimuneoka, Shiki-shi, Saitama
TEL
090-6700-4850
s-sakurai@cli-creative.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ohno |
Organization
Clinical Creative Co., Ltd.
Division name
Pharmaceutical Development Division
Zip code
003-0026
Address
2F 3-Minami 2-18 Hondori, Shiroishi-ku, Sapporo, Hokkaido
TEL
090-3116-6218
Homepage URL
k-ohno@cli-creative.com
Sponsor or person
Institute
Clinical Creative Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yoshindo Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Yurinokai Hospital Clinical Trial Review Committee
Address
11-186 Yurigahara, Kita-ku, Sapporo-shi, Hokkaido
Tel
011-771-1501
info@yurinokai.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
医療法人社団 札幌百合の会病院
Medical Corporation Association Sapporo Yurinokai Hospital
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 15 | 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
| 2025 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 02 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068932
