Effect of Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on Growth and Development of Infants
- Conditions
- Healthy
- Interventions
- Dietary Supplement: breastfeedingDietary Supplement: oligosaccharides and multiple nutrientsDietary Supplement: no oligosaccharides and optimizing multiple nutrients
- Registration Number
- NCT06569797
- Lead Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
- Brief 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.
- Detailed Description
In this clinical trial, the effects of adding oligosaccharides to breast milk and optimizing multiple nutrients in infant formula, conventional infant formula, and breast milk on the growth and development of infants under 1 year old were evaluated by comparing the intestinal indicators (16s rRNA, SCFAs), inflammatory indicators, nutritional indicators, immune indicators, growth and development indicators, bone development indicators, tolerance indicators, cognitive development, adverse events, and serious adverse events of 80 experimental groups, 80 control groups, and 80 breastfeeding groups
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 0-28 days after birth;
- Single birth;
- The gestational age is between 37 and 42 weeks;
- Birth weight ranges from 2500 to 4000 grams;
- Parents or guardians agree not to allow infants to participate in other interventional clinical studies during the study period
- Artificial assisted reproduction;
- The mother suffers from a disease that may endanger intrauterine growth;
- The mother suffers from pregnancy diabetes or serious metabolic disease or chronic disease during pregnancy
- Suffering from congenital malformations and genetic diseases, chronic diseases, and congenital diseases that may interfere with the investigation;
- Suffering from IgE mediated milk protein allergy, or having factors that increase the risk of milk protein allergy;
- Suffering from acute infection or gastroenteritis;
- Suffering from functional gastrointestinal diseases, such as gastroparesis;
- Currently participating in other clinical trials;
- Researchers cannot determine whether parents have the willingness or ability to comply with the requirements of the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Breastfeeding group breastfeeding Breastfeeding with breast milk experimental group oligosaccharides and multiple nutrients Feeding infant formula with added milk oligosaccharides and optimized for multiple nutrients control group no oligosaccharides and optimizing multiple nutrients Feeding with regular infant formula milk powder
- Primary Outcome Measures
Name Time Method Intestinal indicators day 28,180,360 SCFAs
- Secondary Outcome Measures
Name Time Method Inflammatory markers day 180,360 serum hsCRP
Bone development indicators day 180,360 alkaline phosphatase
Tolerance indicators day 28,90,180,360 Bristol stool classification of infant feces
Cognitive Development day 180,360 Serum Amino Acids
Nutritional indicators day 180,360 serum albumin
Immune indicators day 180,360 blood lymphocyte subsets
Growth and development indicators day 28,90,180,360 chest circumference
Trial Locations
- Locations (1)
The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China