Breast Milk Collection Clinical Trial
Official title:
Metabolomic Profile in Breastfed Late Preterm Infants Versus Standard Formula Milk or Postbiotic-supplemented Formula Milk
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04102085 -
the Study of Persistent Organic Pollutants in Human Milk
|
||
Recruiting |
NCT05133466 -
Odour Characteristics of Human Breast Milk of Chinese Mothers
|
||
Completed |
NCT04382989 -
Factors Influencing the Composition of Human Milk
|
||
Completed |
NCT02596295 -
Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
|
N/A | |
Completed |
NCT03675204 -
Establishment of the Breast Milk Database in China
|
||
Completed |
NCT03573531 -
Investigating Lipid Peroxidation Products in Donor Human Milk
|
||
Recruiting |
NCT06203041 -
Vitamin D Sulfates in Breastmilk
|
N/A | |
Not yet recruiting |
NCT05066438 -
The Effect of Prenatal Hand Expression on the Rate of Exclusive Breastfeeding to Two Months
|
||
Recruiting |
NCT03746886 -
Lipids and Other Bioactive Compounds of Human Breast Milk
|
||
Recruiting |
NCT02670278 -
Evolutionary and Sociocultural Aspects of Human Milk Composition
|
N/A | |
Recruiting |
NCT05669690 -
Storage Conditions and Breast Milk Microbiota Composition
|
||
Recruiting |
NCT05943847 -
Neurotrophic Growth Factors in Breast Milk
|
||
Recruiting |
NCT05745922 -
Acute Effects of Endurance Exercise on Breast Milk Composition in Women With Overweight/Obesity
|
N/A | |
Recruiting |
NCT05989009 -
Analysis of Lipids in Human Milk at Different Gestational Ages
|
||
Enrolling by invitation |
NCT05700162 -
The Effect of Showing Photographs, Videos and Live Images of Their Babies to Mothers During Milking
|
N/A | |
Recruiting |
NCT04919265 -
Mother-Infant Cohort Study in Malaysia and China
|
||
Completed |
NCT02535637 -
Breastfeeding and Obesity on Offspring Body Composition
|
N/A | |
Active, not recruiting |
NCT05111990 -
Human Milk and Its Effect on Infant's Metabolism and Infant Gut Microbiome
|
||
Not yet recruiting |
NCT06182449 -
Virtual Reality Distraction for Maternal Milk Expression (PILOT)
|
N/A | |
Recruiting |
NCT06342674 -
Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients
|
N/A |