Infants at High risk of allergy
Conditions
Interventions
Group 2 (pHF-W+HMOs):Partially-Hydrolyzed Whey-Based Formulas (pHF-W+HMOs)
Group 1 (pHF-W):Partially-Hydrolyzed Whey-Based Formulas (pHF-W)
Group 3 (pHF-W+HMOs+Bb-12+FOS):Partially-Hydrolyzed Whey-Based Formulas (pHF-W+HMOs+Bb-12+FOS)
Sponsors
Guangzhou Women and Children's Medical Center,Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1.Gestational age of infants >=37 weeks; 2.Birth weight >=2.5 kg and =75% of the total daily feeding volume) within 24 hours before enrollment. The decision to introduce formula milk feeding should be made independently by parents before enrollment; 7.A written informed consent form voluntarily signed by at least one parent or legal representative (if applicable) must be obtained; 8.Parents/legal representatives of infants should be able to understand informed consent and other study documents and be willing and able to fulfill the requirements of the study protocol; 9.The parents/legal representatives of the infant agreed not to allow the infant to participate in other interventional clinical studies during the period of this study;
Exclusion criteria
Exclusion criteria: 1.Presence of diseases or conditions that may affect oral feeding, growth and development, or study outcomes, including but not limited to: infectious, metabolic, congenital, or hereditary diseases Gastrointestinal diseases (e.g., history of gastrointestinal surgery); 2.Infants requiring special diets or feeding methods, including: infants with special formulas other than standard infant formula (such as deeply hydrolyzed formula, amino acid formula, and formula specifically for metabolic diseases) who need tube feeding; infants diagnosed with allergies (such as atopic dermatitis [AD] and/or milk protein allergy, etc., diagnosed by a doctor); 3.Antibiotics and other supplements (probiotics, prebiotics, synbiotics, postbiotics) have been used or are currently being used one week before enrollment. 4.The infant is participating in or has participated in other interventional clinical trials before enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in relative abundance of Bifidobacteria; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and treatment/medication status;Fecal microbiome;Fecal markers: Secretory immunoglobulin A (sIgA), calprotectin;Growth and development indicators: weight, height, head circumference, Z-score;Infant Gastrointestinal Symptom Questionnaire (IGSQ) score;Frequency and severity of atopic dermatitis (AD); | — |
Countries
China
Contacts
Public ContactZhou Wenhao
Guangzhou Women and Children's Medical Center,Guangzhou Medical University
Outcome results
None listed