Allergy Clinical Trial
Official title:
Effects on Cytokines, Immunoglobulins, Antibodies, Sphingomyelinase and PAF Hydrolysis Capacity in the Maternal Milk After Probiotic VSL#3 Administration in the Last Four Weeks of Gestation and First Month of Lactation
The newborn immune system is influenced by maternal immunity through both placenta and
breastfeeding.
There exists a close interaction between the mother and the baby during gestation and
lactation. Maternal milk contains a number of factors that protect the newborn against
infections including 1) cytokines and their receptors which are also thought to play a role
in the protection against allergies; 2) oligosaccharides with low molecular weight and 3)
probiotic bacteria that contribute to the development of the newborn immune system.
Probiotics have a potent immunogenic activity as well as an immunoprotective potential in
maternal milk after administration of probiotics during pregnancy and breastfeeding. In
addition probiotics are supposed to play a role in the increased production of
sphingomyelinase.
Effects on cytokines, on sphingomyelinase and PAF hydrolysis capacity in the maternal milk
of term newborns after maternal probiotics administration in the last four weeks of
gestation and/or during the first month of lactation.
The newborn immune system is influenced by maternal immunity through both placenta and
breastfeeding.
There exists a close interaction between the mother and the baby during gestation and
lactation. Maternal milk contains a number of factors that protect the newborn against
infections including 1)cytokines and their receptors which are also thought to play a role
(albeit still partially controversial) in the protection against allergies; 2)
oligosaccharides with low molecular weight and 3) probiotic bacteria that contribute to the
development of the newborn immune system.
Probiotics have a potent immunogenic activity as well as an immunoprotective potential in
maternal milk after administration of probiotics during pregnancy and breastfeeding. In
addition probiotics are supposed to play a role in the increased production of
sphingomyelinase, and other enzymes.
Aim of the study
Assessment of the breast milk of women who delivered healthy term babies, as well as of
other parameters including the immunomodulatory effect, sphingomyelinase concentration and
PAF hydrolysis capacity after administration of the probiotic VSL#3 (VSL Pharmaceuticals) to
the mothers in the last four weeks of gestation and in first month of breastfeeding.
Controlled Blind Prospective Study. Group 1 (maternal milk/ cases): 30 mothers in the last
four weeks of gestation and in the first month of breastfeeding. All mothers will be given
(after obtaining their informed consent) probiotics (VSL#3) during the last four weeks of
pregnancy and the first month of breastfeeding under the usual dosage scheme (1 sachet/day,
before meal); Group 2 (maternal milk/controls): 30 mothers in the last for weeks of
gestation and in the first month of breastfeeding. These mothers will not be given the
probiotics in question.
Groups 1 and 2 will undergo assessment of the concentrations of immunoglobulins (secretory
IgA), TGF-beta, IL 10 e IL 6, as well as assessment of sphingomyelinase and PAF hydrolysis
capacity in colostrum (3-4 days of lactation), in transition milk (1st week of lactation),
in mature milk (after the 1st week of lactation) and at the end of the first month of
lactation. The samples will be analyzed for the probiotic microorganisms. Furthermore, in
parallel, metabolic profiles by 1HNMR spectroscopy will be performed on the same samples of
colostrum, transition and mature milk.
The same cytokines, immunoglobulins, sphingomyelinase and PAF hydrolysis capacity and
microbiota will be then assessed in the faeces of the newborns on the same days.
The data of each subject enrolled in the study will be collected in Data Sheet which will
also include the assessment of the mother's risk of allergy.
A Data Sheet will also be envisaged for each newborn enrolled in the study which will also
include daily assessments of gastric stagnation, vomit episodes and abdominal distension.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention
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