Influence of Probiotic VSL#3 Administration on Metabolic and Immunological Profile of the Milk of Breastfeeding Mothers
Condition: Allergy
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): VSL#3 probiotic preparation; Placebo VSL#3
Intervention type(s): Dietary Supplement; Other
Intervention description(s): VSL#3 is a mixture of 8 different strains of lactic acid bacteria and bifidobacteria at a concentration of 900 billion bacteria per sachet. The suggested dosage is 1 to 2 sachets per day.; Placebo VSL#3 is a base of corn starch containing no active ingredient.
Other intervention name(s): VSL#3; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention