None
Conditions
Interventions
Consumption of test foods containing high-dose probiotics until the one-month health check-up
Consumption of test foods containing low-dose probiotics until the one-month health check-up
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Infants within 7 days of birth 2. Infants with a gestational age of 37 weeks or more but less than 42 weeks 3. Infants for whom written consent has been obtained from a legal guardian (or surrogate) 4. Infants assessed by the principal investigator as being in good health
Exclusion criteria
Exclusion criteria: 1. Infants who do not plan to use formula milk during the study period 2. Infants who have or are at risk of having allergies to milk, soy, or neonatal/infant gastrointestinal allergies, making it difficult to feed them regular infant formula 3. Infants born from multiple births 4. Infants with a birth weight of less than 2,500 g or more than 4,000 g 5. Infants who have been administered probiotics or antibiotics 6. Infants with suspected or congenital severe diseases of the blood, liver, heart, kidneys, digestive system, or suspected immunodeficiency 7. Infants whose mothers have severe liver, kidney, cardiovascular, respiratory, endocrine, metabolic disorders, or psychiatric disorders 8. Infants who plan to use probiotics or prebiotics other than the test food during the study period 9. Infants deemed inappropriate as subjects by the principal investigator based on background, physical findings, examinations, physical tests, and clinical test results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection count and presence of probiotic strains from the test food in feces | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Detection and presence of Bifidobacteria in the gut microbiota, and the count of Bifidobacteria in feces 2. Indicators related to the gut microbiota (occupancy rate and presence of each gut bacterium, diversity measures, etc.) 3. Frequency of bowel movements and stool characteristics | — |
Countries
Japan
Contacts
Public ContactEriko Yokoshima
KSO Corporation Clinical Trial Management Department
Outcome results
None listed