The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides. The primary objective of the trial is to demonstrate the safety of the new infant formula supplemented by comparing the growth of infants randomized to the experimental formula versus the control formula from enrollment to the age of 4 months. The study has an interventional phase up to 6 months of age including 5 visits followed by an observational phase up to 12 months of age for a subgroup of the first 50 breastfed infants and the first 110 formula-fed infants including 2 additional visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
326
Infants are fed with HMO formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months.
Infants are fed with standard formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months.
Affiliated Hospital of Jining Medical College
Jining, China
RECRUITINGShanghai Public Health Clinical Center affiliated to Fudan University
Shanghai, China
RECRUITINGXinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGThe Third People's Hospital affiliated to Hebei Medical University
Shijiazhuang, China
RECRUITINGThe First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, China
RECRUITINGWeight gain (g/day) between enrollment and the age of 4 months
Time frame: until the age of 4 months
Fecal secretory IgA (mg/g dry feces) at the age of 4 months corrected for baseline values
Time frame: until the age of 4 months
Weight (g) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Body length (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Body length gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Head circumference (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Head circumference gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Weight-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Length-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Weight-for-length WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Head-circumference-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Weight gain (g/day) between enrollment and the age of 6 months and 12 months respectively
Time frame: until the age of 12 months
Stool pattern, GI symptoms and GI-related behaviors recorded in the retrospective 1-day questionnaire at baseline and in the prospective 3-day GI Symptom and Behavior Diary for 3 days prior to the age of 42 days, 3 months, 4 months, 6 months
Time frame: until the age of 6 months
Fecal microbiome composition, diversity, community type assessed by NGS sequencing at baseline, the age of 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Fecal acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid, isovaleric acid, and total short chain fatty acids at baseline, the age of 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Fecal pH at baseline, the age of 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Fecal secretory IgA (mg/g dry feces) at the age of 6 months corrected for baseline values
Time frame: until the age of 6 months
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