Dysbacteriosis
Conditions
Interventions
Intervention group:Take 1 bag of the bacterial powder containing Streptococcus thermophilus N1115 every day, 2g per bag. The concentration of Streptococcus thermophilus Lp N1115 in it is 1×10^10 CFU/g
Control group:Take one bag of placebo (pure maltodextrin) with the same packaging daily, 2g per bag, using the same method of administration.
Exclusively breastfed control group:Recruit 70 exclusively breastfed infants who will undergo follow-up visits for anthropometric measurements and the collection of stool and saliva samples.
Sponsors
Peking University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy infants aged 0-6 months who were delivered at full term, and whose inclusion criteria met the standards for healthy infants of the corresponding age group, with their parents being able to understand the agreement requirements and complete the infant diaries as required; 2. Healthy, single or twin births, gestational age >= 37 weeks (WHO), birth weight >= 2500g, current weight falling between P20 and P80 on the percentile chart for children aged 0-18 years; 3. The formula of the infant formula milk powder used for feeding does not contain probiotics; it can only contain low-galactooligosaccharide (GOS) < 2g/100g as prebiotics, and no low-fucose.
Exclusion criteria
Exclusion criteria: 1. Severe diseases or deformities; mothers with metabolic and/or chronic diseases; 2. During the research period, intake of other drugs that may affect the efficacy and/or influence the judgment of the results, due to the inability to determine the efficacy of probiotics and/or affect the judgment of the results; 3. Current or previous diseases or conditions or intervention measures may interfere with the research (affecting tolerance and/or growth and development), such as gastrointestinal malformations, chronic diarrhea, malabsorption syndrome, malnutrition, congenital immune deficiency or major surgery; 4. Oral antibiotics or other drugs containing probiotics and prebiotics (except infant formula milk) were taken within 2 weeks before the intervention; 5. Acute exacerbation period of gastrointestinal diseases; 6. Special medical food with non-standard formula powder for lactose intolerance and galactosemia; 7. Infants with probiotic allergy or possible food allergy (such as milk); 8. 4 weeks before the intervention, participated in or had participated in other clinical studies; 9. The legal guardian of the infant does not have the ability to sign the informed consent form or record the research content (due to mental illness, language disorder, drug addiction, etc.); 10. Subjects who do not comply with random grouping.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal flora;sIgA;Weight;Height;Head circumference; | — |
Countries
China
Contacts
Public ContactYumei Zhang
Department of Nutrition and Food Hygiene, School of Public Health, Peking University
Outcome results
None listed