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临床试验/NCT06052592
NCT06052592已完成不适用

Metabolomic Profile in Breastfed Late Preterm Infants Versus Standard Formula Milk or Postbiotic-supplemented Formula Milk

Ospedale Buon Consiglio Fatebenefratelli2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants

研究概览

简要总结

Exclusive breast milk is recommended from birth to 6 months of life to promote the development of a balanced intestinal microbiota. Human milk provides several bioactive components, from natural probiotics such as Bifidobacterium spp. and Lactobacillus spp., to their metabolites which colonize the intestine of the newborn. However, if breast milk is not available or insufficient, it is used formula milk as a substitute. Infant formula can be supplemented with postbiotics to promote maturation of immune, metabolic and microbial components, similar to breast milk. Postbiotics are preparations composed of both microbial constituents and their metabolites, produced during fermentation.

详细描述

A balanced nutrition starting from early childhood significantly influences growth and psychomotor development. Exclusive breast milk is the recommended nutritional choice from birth to 6 months of life, as it guarantees everything necessary for growth, maturation, protection from infections, promoting the development of a balanced intestinal microbiota. Several prenatal and perinatal factors including the type of delivery, the use of antibiotics, diet and other environmental factors, can influence the microbial colonization of the newborn. Thus, it is generally accepted that the gut microbiota of the healthy, full-term, vaginally born, breastfed infant is the gold standard for a favorable microbial composition in the early years of life. Human milk provides several bioactive components, from natural probiotics such as Bifidobacterium spp. and Lactobacillus spp., to their metabolites ("natural postbiotics"), which colonize the intestine of the newborn. These metabolites regulate the development of the immune system and attenuate the inflammatory processes. However, if breast milk is not available or insufficient to meet the nutritional needs of the infant, formula milk is proposed and used as a substitute. Given the benefits, it is essential that infant formula is as close to human milk as possible, providing bioactive substances that target gut and immune system health. Current research focuses on optimizing artificial formulas, with the aim of resembling human milk in composition and functionality, with some on the market already including probiotics, prebiotics, synbiotics and postbiotics. However, it still remains to be clarified which is the best formulation and the exact consequences on the immune, metabolic and microbial system of the newborn. In particular, postbiotics are preparations composed of both microbial constituents and their metabolites, produced during fermentation. It has already been highlighted in the literature that the enrichment of formula milk with post-biotics would seem to offer advantages for feeding term infants. Furthermore, it promotes an immune, metabolic and microbial component maturation, similarly to human milk, thus making postbiotic supplements very promising and interesting in the nutrition of newborns and infants.

研究设计

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

入排标准

年龄范围
34 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Weight appropriate to gestational age (percentiles >10th and <90th)
  • Written informed consent

排除标准

  • Cardiological diseases
  • Liver disease
  • Gastrointestinal diseases with malabsorption
  • Endocrinological diseases
  • Perinatal infections
  • Metabolic and genetic diseases
  • Born to mothers with endocrinological and metabolic diseases
  • Withdrawal of informed consent

结局指标

主要结局

Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants

时间窗: 3 months after delivery

To detect the differences in the metabolome of the newborns

次要结局

未报告次要终点

研究者

发起方
Ospedale Buon Consiglio Fatebenefratelli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe De Bernardo

Head of Department of Woman and Child

Ospedale Buon Consiglio Fatebenefratelli

研究点 (2)

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Metabolomic Profile in Breastfed Late Preterm Infants | 临床试验