Clinical trial NCT01367470: Influence of Probiotic VSL#3 Administration on Metabolic and Immunological Profile of the Milk of Breastfeeding Mothers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergy
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* able to give informed consent

Exclusion Criteria:

* twin pregnancies, pregnancy diseases (threat of miscarriage, maternal chronic conditions)

Primary outcomes:
measure: Effect of VSL#3 probiotic administration on breast milk
timeFrame: 2 months
Secondary outcomes:
measure: Assessment of sphingomyelinase concentration in breastmilk of mothers
timeFrame: 2 months
measure: Assessment of PAF hydrolysis in breastmilk of mothers
timeFrame: 2 months
measure: Assessment of fecal newborn microbiota
timeFrame: 2 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
city: Bari
country: Italy
facility: to Be Confirmed
Study officials:
affiliation: Bari University
name: Maria Elisabetta Baldassarre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.
citation: Vitali B, Cruciani F, Baldassarre ME, Capursi T, Spisni E, Valerii MC, Candela M, Turroni S, Brigidi P. Dietary supplementation with probiotics during late pregnancy: outcome on vaginal microbiota and cytokine secretion. BMC Microbiol. 2012 Oct 18;12:236. doi: 10.1186/1471-2180-12-236.