Effect of Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on Growth and Development of Infants
NCT Number: NCT06569797
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: oligosaccharides and multiple nutrients|DIETARY_SUPPLEMENT: no oligosaccharides and optimizing multiple nutrients|DIETARY_SUPPLEMENT: breastfeeding
Sponsor: Heilongjiang Feihe Dairy Co. Ltd.
Sex: ALL
Age: CHILD
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-01-08
Completion Date: 2025-09-30
Locations: The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army, Beijing, Beijing, 100000, China

Summary:
The research objective is to compare the effects of infant formula supplemented with milk oligosaccharides and optimized with multiple nutrients on the immune function of infants under 1 year old with conventional infant formula, and to compare the effects of different infant formulas on infant intestinal health, immune function, growth and development, cognitive development, and tolerance with those of breastfed infants.

Primary Outcome Measures: Intestinal indicators, 16s rRNA, day 28,180,360|Intestinal indicators, SCFAs, day 28,180,360
Secondary Outcome Measures: Inflammatory markers, serum hsCRP, day 180,360|Nutritional indicators, serum albumin, day 180,360|Immune indicators, fecal sIgA, day 28,180,360|Immune indicators, blood lymphocyte subsets, day 180,360|Growth and development indicators, height, day 28,90,180,360|Growth and development indicators, weight, day 28,90,180,360|Growth and development indicators, head circumference, day 28,90,180,360|Growth and development indicators, chest circumference, day 28,90,180,360|Bone development indicators, osteocalcin, day 180,360|Bone development indicators, alkaline phosphatase, day 180,360|Tolerance indicators, investigation of infant gastrointestinal comfort：In the past week, the average daily number of reflux .The minimum number is 0, and there is no limit to the maximum number., day 28,90,180,360|Tolerance indicators, investigation of infant gastrointestinal comfort：In the past week, abdominal pain VAS score of the infant.The minimum score is 0, and the maximum score is 10., day 28,90,180,360|Tolerance indicators, investigation of infant sleep crying：In the past week, the average daily crying time.The minimum time is 0 hours and the maximum time is 24 hours., day 28,90,180,360|Tolerance indicators, investigation of infant sleep crying：In the past week, the average daily crying frequency.The minimum number of times is 0, and the maximum number of times is unlimited., day 28,90,180,360|Tolerance indicators, investigation of infant sleep crying：In the past week, the average daily crying severity. The severity of crying is divided into no crying, mild crying, moderate crying, very crying, and extreme crying., day 28,90,180,360|Tolerance indicators, investigation of infant sleep crying：In the past week, the average daily crying daytime and nighttime sleep duration. The minimum time is 0 hours and the maximum time is 12 hours., day 28,90,180,360|Tolerance indicators, investigation of infant sleep crying：In the past week, sleep problems of infants.Sleep problems are divided into no problem, minor problem, moderate problem, major problem, and extreme problem., day 28,90,180,360|Tolerance indicators, investigation of infant diarrhea and upper respiratory tract infections：The severity of diarrhea and upper respiratory tract infections (colds) in infants from birth until now. The severity level is classified as no problem, minor problem, moderate problem, major problem, and maximum problem., day 28,90,180,360|Tolerance indicators, Bristol stool classification of infant feces, day 28,90,180,360|Cognitive Development, Bailey Infant Development Scale (Version IV) Score（130 or above, very excellent; 120-129, excellent; 110\~119, upper middle; 90-109, moderate; 80-89, below average; 70-79, critical state; Below 69, developmental delay）, day 28,90,180,360|Cognitive Development, Serum Amino Acids, day 180,360
Other Outcome Measures: adverse event, adverse event, 1 year|Serious adverse events, Serious adverse events, 1 year