None
Conditions
Interventions
Research product group-1:Formula-1 supplemented with breast milk oligosaccharides
Research product group-2:Formula-2 supplemented with breast milk oligosaccharides
Control product group:Formula without the addition of breast milk oligosaccharides
Sponsors
Beijing Children's Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 0.1 Years
Inclusion criteria
Inclusion criteria: 1. According to the baby's medical history, the baby is in good health. 2. Healthy full-term infants (gestational age =37 weeks +0 days and =41 weeks +6 days). 3. Birth weight =2500 g and =4500 g. 4. Arkhardt score =7 at 5 minutes after birth. 5. Infant age =14 days (date of birth = day 0) when enrolled. 6. Infants in the breastfeeding control group must meet the following conditions: infants were mainly breastfed after birth and were exclusively breastfed for =3 days before entering the group. The baby's parents/legal guardians have independently decided to exclusively breastfeed the baby until the baby reaches 4 months of age (exclusive breastfeeding means that the baby's only source of feeding is breast milk). 7. Infants in the formula feeding group must meet the following conditions: the infant was primarily fed with infant formula prior to enrollment, and the parent/legal guardian representative of the infant had independently decided before enrollment that the infant should be fed exclusively with infant formula until the infant reached 4 months of age (exclusive formula feeding means that the infant's sole source of feeding is formula). 8.Written informed consent signed by the baby's parents/legal guardians.
Exclusion criteria
Exclusion criteria: 1. Diets other than those prescribed in the feeding programme are required. 2. Maternal, fetal, or participant medical history of conditions or conditions that may be associated with increased risk or potential effects on gastrointestinal tolerance, growth, and/or development due to participation in this study, including: Congenital malformations (cleft lip and palate, digestive tract malformations, limbs malformations, etc.), acute infections or gastroenteritis, systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis), metabolic disorders, etc. 3. According to the judgment of the researcher, abnormal laboratory examination has made it unfit to participate in the research. 4. The mother had gestational diabetes mellitus and other metabolic and chronic diseases at the time of pregnancy. 5. Prior to enrollment had received or was receiving drugs or supplements that may have affected the study results, such as antibiotics, pancreatic enzymes, glycerol suppositories, polycuryl esters, maltose or lactulose, insulin or growth hormone, prebiotics or probiotics. 6. Have been diagnosed with milk protein allergy or other allergic disease. 7. Are or have participated in other clinical trials. 8. Failure to comply with the feeding requirements of the scheduled visit and study programme. 9.Other conditions deemed unsuitable for participation in the study were determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anthropometry; | — |
Secondary
| Measure | Time frame |
|---|---|
| Increment of growth parameters;Assessment of gastrointestinal symptoms;Changes in fecal characteristics; | — |
Countries
China
Contacts
Public ContactJie Wu
Beijing Children's Hospital,Capital Medical University
Outcome results
None listed