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 of the following inclusion criteria are eligible to participate in this study: 1. Parents or legal guardians aged = 18 signed the written informed consent; 2. Term infants (37 weeks+0 days = gestational age = 41 weeks+6 days); 3. Chinese nationality; 4. Birth weight = 2500 g and = 4000 g; 5. Meet the diagnostic criteria for gastrointestinal discomfort at the time of enrollment; 6. At the time of enrollment/randomization, the age of the infant was = 59 days (56+3 days) (birth date=day 0); 7. Infants must meet all of the following inclusion criteria to be eligible for the study: a) Formula fed group 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 group 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. It is necessary to feed foods other than those specified in this protocol. 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. Drugs or supplements that may affect the results have been or are being received before enrollment, such as antibiotics, pancreatic enzymes, glycerol suppositories, polyesters, maltose or lactulose, probiotics or prebiotics. 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 protocol requirements. 8. The investigator judged that other conditions were not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the score of the Infant Gastrointestinal Symptom Questionnaire (IGSQ); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in fecal characteristics;Increment of growth parameters;Changes in infant quality of life scores; | — |
Countries
China
Contacts
Public ContactZailing Li
Peking University Third Hospital
Outcome results
None listed