healthy person
Conditions
Interventions
Lactobacillus reuteri: Capsules containing 100 billion CFU (colony-forming units) of Lactobacillus reuteri per day
Placebo group: Capsules identical in appearance and taste but not containing Lactobac
Sponsors
Clinical Creative Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKazuhiro Ohno
Clinical Creative Co., Ltd. Pharmaceutical Development Division
Outcome results
None listed