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临床试验/NCT05297006
NCT05297006Unknown不适用

Regulation and Mechanism of New Compound Functional Ingredients on Intestinal Microecology and Immune Function in Infants

Peking University Third Hospital3 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
试验地点
3
主要终点
Growth and development indexes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Healthy infants;
  • Full-term (gestational age ≥37 weeks);
  • Birth weight 2500-4500g;
  • Mothers have no history of diabetes, hypertension, heart disease, and other diseases during pregnancy;
  • The guardian signed informed consent and voluntarily enrolled into the group and promised to complete systematic follow-up.

排除标准

  • Hospitalization with cognitive impairment or deformity ≥2 days
  • History of birth asphyxia (Apgar score < 3)
  • Severe allergy to milk and serious medical conditions such as intracranial hemorrhage, chronic diarrhea, necrotizing colitis, or acute infection
  • The guardian refused to enroll or could not complete the system follow-up.

结局指标

主要结局

Growth and development indexes

时间窗: 12 months

Baby body head circumference gain

Neurodevelopmental level

时间窗: 6 months

The Peabody scale was used to assess the level of neural development of infants at 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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