Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Change from baseline Innate immunity at 30 days of life and at 90 days of life.
Study Overview
Brief Summary
This is a single-center, double-blind, randomized controlled trial, with parallel groups and reference group. The aim of the study was to investigate whether feed a fermented formula milk leads to an increase of anti-microbial peptides such as catelecidine, alpha and beta defensins and secretory-IgA, compared to feed a standard formula (Plasmon Primigiorni), according to mode of delivery. Breastfed infants were the reference group.
Detailed Description
The microbiota plays an important role in modulating the development of the immune system, making decisive the interrelation that between nutrition, microbiota and immune cells to modulate long-term health outcomes.
The type of feeding, especially breastfeeding, and the type of delivery are factors that can contribute to the development of the microbiota. Specifically, the exclusive breastfeeding promotes the development of bifidobacteria that promotes protection against potential infections and the development of the immune system.
In recent years it was improved the biological effects of formula milk, that represent the substitutes of breast milk when this is not available or if there are contraindications to breastfeeding. Functional foods derived from fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases of the child. Recently, in a monocentric double-blind prospective study, the efficacy of fermented cow's milk with Lactobacillus paracasei CBA L74 was evaluated in the prevention of common winter infections in children aged between 12 and 48 months. In this study, children treated with fermented milk had a lower incidence of respiratory and gastrointestinal tract infections compared to the control group. This effect was associated with a significant stimulation of innate immunity (α- and β-defensin, LL-37) and acquired (secretory IgA) and to a modulation of composition and function of the intestinal microbiota characterized by a significant increase in strains producing butyric acid (Firmicutes phyla). The nutritional intervention was very well accepted by the children and no adverse events were observed.
Primary objectives of this study were:
To evaluate whether the feeding with a fermented formulated milk determines an increase in anti-microbial peptides such as catelecidine, alpha and beta defensin and secretory IgA compared to the feed with the standard formula (Plasmon Primigiorni), with reference to the mother's milk.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 1 Day to 7 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Full term healthy infants
- •Gestational age from 37 to 41 weeks
- •Weight appropriate for gestational age (from 10th to 90th centile according to World Health Organization chart)
- •Human milk not available or not possible
Exclusion Criteria
- •Weight small for gestational age (< 10th centile) or large for gestational age (> 90th centile) according to World Health Organization chart
- •Congenital abnormalities, chromosomal, hearth, gastrointestinal, respiratory, neurological or metabolic disease.
- •Perinatal infections
- •Positive familiarity for milk proteins allergies
Arms & Interventions
Infants born by CS-fed fermented formula
Feeding infants with fermented formula milk. Infants born by cesarean section were fed either with fermented formula milk or with standard formula during the first 3 months of life
Intervention: Feeding infants with fermented formula milk (Dietary Supplement)
Infants born by CS-fed standard formula
Feeding infants with standard formula milk. Infants born by cesarean section were fed either with fermented formula milk or with standard formula during the first 3 months of life
Intervention: Feeding infants with standard formula milk (Other)
Infants born by CS-breastfed
Infants born by cesarean section fed with mother milk during were the reference group for all infants born by cesarean section.
The breastfeeding infants were the reference group
Intervention: Breastfeeding infants (Other)
Infants born by ED-fed fermented formula
Feeding infants with fermented formula milk. Infants born by eutocic delivery were fed either with fermented formula milk or with standard formula during the first 3 months of life
Intervention: Feeding infants with fermented formula milk (Dietary Supplement)
Infants born by ED-fed standard formula
Feeding infants with standard formula milk. Infants born by eutocic delivery were fed either with fermented formula milk or with standard formula during the first 3 months of life
Intervention: Feeding infants with standard formula milk (Other)
Infants born by ED-breastfed
Infants born by eutocic delivery were fed either with fermented formula milk or with standard formula during the first 3 months of life.
The breastfeeding infants were the reference group.
Intervention: Breastfeeding infants (Other)
Outcomes
Primary Outcomes
Change from baseline Innate immunity at 30 days of life and at 90 days of life.
Time Frame: 0-7 days of life, at 30 days of life and at 90 days of life.
Fecal dosage of catelecidines, alfa and beta defensins and sIgA
Secondary Outcomes
- Gastrointestinal tolerance(0-7 days of life, at 30 days of life and at 90 days of life.)
- Weight(0-7 days of life, at 30 days of life and at 90 days of life.)
- Body composition(0-7 days of life and at 90 days of life.)
- Anthropometry(0-7 days of life, at 30 days of life and at 90 days of life.)
- Microbiota(0-7 days of life and at 90 days of life.)
- Metabolomics(0-7 days of life and at 90 days of life.)