Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06052592 |
| Other study ID # |
1680 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
November 1, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Ospedale Buon Consiglio Fatebenefratelli |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
