Innate Immunity Clinical Trial
Official title:
Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery
This is a single-center, double-blind, randomized controlled trial, with parallel groups and
reference group.
The aim of the study was to investigate the immunity of infant born from caesarian section
and fed with formula milk containing fermented matrix a double and triple dosage compare the
first part of the trial FERCT15 assuming a dose-effect relationship of the fermented matrix
with immune response.
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.
From previous results emerged that in infants born by eutocic delivery fed with fermented
formula milk, there is more valid response of innate and acquired immunity compare to
controls. In infants born by cesarean section this response is less expressed. It is possible
to suppose that this response is linked to a different microbiota.
Primary objectives of this study were:
to investigate the immunity of infant born from caesarian section and fed with formula milk
containing fermented matrix a double and triple dosage compare the first part of the trial
FERCT15 assuming a dose-effect relationship of the fermented matrix with immune response.
Secondary objective:
Value the tolerance in the two groups of infants fed with the two formulas in the study, with
reference to the group of infants fed with breast milk.
Value the modifications of the intestinal microbiota in the 3 groups of infants fed with the
3 formulas in the study, with reference to the group of infants fed with breast milk.
Study design: Single-center, randomized, double-blind, parallel group study with reference
group.
Methods:
Evaluation of the anthropometric parameters (weight, length and cranial circumference)
Evaluation of body composition by plethysmography Evaluation of the gastrointestinal
tolerance of fermented formulated milk by means of data collection and diary delivery to the
parents of the participants Evaluation of the safety of fermented formulated milk by
recording adverse events Determination of faecal samples of antimicrobial peptides
(defensins, catelecidines), IgA, microbiota and metabolome.
Infants will be enrolled at birth (within 7 days of life) upon acquisition of the informed
consent of both parents.
At the time of enrollment, infants born by caesarian section who take breast milk due to the
absence of breast milk will be randomized to receive up to the third month of age or a
standard formula without fermented matrix (control group) or a formula milk containing
fermented matrix at dosage of 4.6 g per 100g of powder (group fed with double dosage of
fermented matrix compare to FERCT15) or formula milk containing fermented matrix at dosage
6.9 g per 100g of powder (group fed with triple dosage of fermented matrix compare trial
FERCT15).
Enrollment will be carried out by promoting and supporting breastfeeding and, in the event of
exclusive breastfeeding forecasts for at least the first 3 months of age, newborns will be
included in the study as a reference group.
There are 3 medical visits to enrollment (V0), the first (V1) and the third month of life
(V2).
During the visits the anthropometric parameters, the body composition, and the gastroenteric
tolerance will be evaluated. A stool sample will also be collected at the three points of the
life study to determine the anti-microbial peptides (catelecidine, alpha and beta defensin)
and the secretory IgA, and perform the analysis of the microbiota and the metabolome.
Statistical analysis:
The sample size was determined considering the secretory IgA values obtained in the FERCT15
trial.
The fecal secretory IgA mean value was 78,3 ±34,37ug/g and of 43,86±30,44 ug/g of feces in
the group fed with formula milk with fermented matrix (dosage of 2,3g/100g of powder) and
with the standard formula respectively.
Assuming a 15% drop-out rate, 14 newborns per group must be recruited.
Criteria for the evaluation of variables:
The descriptive analyzes will be performed by calculating mean, median and standard
deviations for the continuous variables and expressing the distribution of the frequencies
for the discrete variables. The main analysis will resort to tests for independent samples,
Student or Mann-Whitney tests according to the distribution of the outcome variables. To
jointly analyze the trend in time from V0 to V2 of the outcome variables in the two groups,
the one that received the fermented formulated milk and the one that received the standard
formula, based on the type of delivery (spontaneous or cesarean) will be used regression
models for repeated measurements (random effects models or GEE models).
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