none
Conditions
Interventions
test group:Biostime brand probiotics infusion
Sponsors
Children's Hospital Affiliated to Soochow University
Eligibility
Sex/Gender
All
Age
No minimum to 2 Years
Inclusion criteria
Inclusion criteria: 1. Healthy infants, gestation >= 37 weeks of single birth (i.e., non-preterm infants), birth weight >= 2500 g; 2. The monthly age of infants is 0-24 months; 3. Priority should be given to infants who are fed with pure formula, or whose daily intake of pure formula is greater than or equal to 80% of the total daily intake of milk (i.e. the total intake of breast milk and formula milk) (or who are breastfed less than twice a day); 4. The subject's parent or legal guardian agrees to use the infant formula recommended in this study (i.e. free of probiotics and containing less than 4g fructooligosaccharides and galactose oligosaccharides per 100g of formula); 5. Infants and toddlers have not taken probiotic products in the past month; No other dietary supplements containing probiotics or prebiotics were taken during the study; 6. The subject's parent or legal guardian can understand and fill in the infant diary card as required; 7. The subject's parents or legal guardians give informed consent and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Infants and young children who have taken probiotic/prebiotic dietary supplements or formula containing probiotics/high-dose prebiotics (more than 4g fructooligosaccharides or galactose oligosaccharides per 100g of formula) within one month before participating in the trial; 2. Infants who had received antibiotics within one month before participating in the study (for infants less than 1 month old, the time period was calculated from the date of birth to the day before enrollment); 3. Infants and young children with severe infections or who have undergone any gastrointestinal surgery; 4. According to the clinical judgment of the researcher, the infant or child has current or previous diseases/conditions that may interfere with the study, such as gastrointestinal malformation, chronic diarrhea, malabsorption syndrome, malnutrition, congenital immune deficiency, severe cardiopulmonary disease, congenital genetic metabolic disease, etc.; 5. Infants who had used immunosuppressive drugs (such as glucocorticoids and immunosuppressants) before enrollment or during the intervention; 6. Infants and children who are sensitive to known probiotics or allergic to oligosaccharides and maltodextrin ingredients; 7. Infants who participated in clinical trials of other drugs or medical devices within 1 month prior to screening (for infants less than 1 month old, the time period was calculated from the date of birth to before enrollment); 8. Cannot follow the doctor's advice; 9. Premature or low birth weight infants; 10. Infants and young children considered unsuitable for this study by researchers for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The immune indexes;Intestinal flora;Disease symptoms;Metabolomics of flora; | — |
Secondary
| Measure | Time frame |
|---|---|
| flut-2; | — |
Countries
China
Contacts
Public ContactXi yuandi
Capital Medical University
Outcome results
None listed