None
Conditions
Interventions
Research product group :Partially hydrolyzed formula
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all the following inclusion criteria can participate in this study: 1. Parents or legal guardians aged = 18 sign written informed consent; 2. Healthy full-term infants (37 weeks+0 days = gestational age = 41 weeks+6 days); 3. Chinese nationality; 4. Birth weight = 2500 g and = 4000 g; 5. According to the anaphylaxis assessment questionnaire, the researcher judged that anaphylaxis was at high risk; 6. At the time of enrollment/randomization, the age of the infant is = 16 days (14+2 days) (birth date=0 day); 7. Infants must meet all the following inclusion criteria to be eligible for the study: a) Infants fed with formula only: The infants were mainly fed with formula before enrollment, and their parents/legal guardians had independently chosen to feed with formula during the study period before enrollment. Formula feeding means that the main source of nutrition for infants is formula milk powder. b) Breast-fed infants only: infants are mainly breast-fed before enrollment, and their parents/legal guardians decide to continue to be breast-fed during the study period before enrollment. Breastfeeding means that the main source of nutrition for infants is breast milk.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria will not participate in this study: 1. Infants who need to feed foods other than those specified in the program. 2. According to the judgment of the investigator, there are related diseases or medical conditions that may increase the risk or interfere with the results due to participation in this study, including congenital malformation, systemic or congenital infection, metabolic disorder, etc. 3. According to the judgment of the investigator, there is an abnormality in the laboratory examination that makes him unfit to participate in the study. 4. Before joining the group, they have received or are receiving drugs or supplements that may affect the research results, such as antibiotics, pancreatic enzymes, glycerol suppositories, polyesters, maltose or lactulose, etc. 5. Have been diagnosed as milk protein allergy or other allergic diseases. 6. Is or has participated in other clinical trials. 7. Unable to comply with the scheduled visit and research protocol requirements. 8. The investigator judged that other conditions were not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal allergy;Atopic dermatitis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of gastrointestinal symptoms;Changes in fecal characteristics;Increment of growth parameters; | — |
Countries
China
Contacts
Public ContactZailing Li
the Third Hospital of Peking University
Outcome results
None listed