An observational study in Sialic Acid and Oligosaccharide, sponsored by Peking University Third Hospital. Status unknown at 3 sites in China. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by Peking University Third Hospital · Observational
A prospective, multicentre, randomized, double-blind, parallel control study was conducted to analyze the changes in growth, intestinal flora, and immune function of infants with different feeding patterns from postnatal to 1 year of age.
Breast milk is the most beneficial and safe natural food for the growth and development of infants, but some mothers cannot complete breast feeding.For infants who cannot be breastfed, how to improve the composition of formula milk powder and improve the growth and development of infants is an important issue to be solved urgently in this field.It has been found that new compound functional ingredients oligosaccharides and sialic acid may be beneficial to the healthy growth and development of infants and young children, but the specific mechanism and significance are still unclear due to the lack of systematic research.Known as the "second Brain", the gut is connected to the Brain via the brain-gut-axis.Intestinal microecological status can significantly affect the development of infant nervous system and immune system, and then affect the occurrence of related diseases in adulthood.Oligosaccharides and sialic acid may affect the structure of intestinal microecology, protect the immune function of infants and promote the healthy development of infants.This project is based on the previous studies, using multicenter, prospective, randomized, double-blind, parallel-group trial, discussion of oligosaccharides and sialic acid in infants and young children the intestinal micro ecology and the regulation of immune function and the role mechanism, revealing the oligosaccharides and sialic acid in infants and young children the role of immediate and long-term growth, and the significance of these new type of composite function is added to the dairy ingredients, to research and development more accord with our country new dairy products provide theoretical basis for the healthy growth of infants and young children.
Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
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Breastfeeding group The mother can breastfeed exclusively until the infants is at least 4 months old, after which complementary foods are added scientifically according to the baby's condition.
Formula group containing new compound functional ingredients Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.
Formula group containing new compound functional ingredients Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.
Exclusion Criteria:
The mother can breastfeed exclusively until the infants is at least 4 months old, after which complementary foods are added scientifically according to the baby's condition.
Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.
Dietary Supplement: The infants who drank milk powder were given a dietary intervention four months before
Only use formula milk powder without oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.
Dietary Supplement: The infants who drank milk powder were given a dietary intervention four months before
The infants who eat milk powder were randomly divided into two groups: group containing new compound functional ingredients and group without new compound functional ingredients
Growth and development indexes
Baby body length, weight, head circumference gain
Time frame: 12 months
Growth and development indexes
Baby body weight gain
Time frame: 12 months
Growth and development indexes
Baby body head circumference gain
Time frame: 12 months
Neurodevelopmental level
The Peabody scale was used to assess the level of neural development of infants at 4 months and 6 months
Time frame: 4 months
Neurodevelopmental level
The Peabody scale was used to assess the level of neural development of infants at 6 months
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital