Influence of Probiotic VSL#3 Administration on Metabolic and Immunological Profile of the Milk of Breastfeeding Mothers

NCT ID: NCT01367470

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-12-31

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.

Conditions

Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

VSL#3 probiotic preparation

30 mothers in the last 4 weeks of gestation and in the first month of breastfeeding will be given (after obtaining their informed consent) 1 sachet per day of probiotics (VSL#3) during the last four weeks of pregnancy and the first month of breastfeeding for four weeks under the usual fasting dosage scheme (1 sachet before meal).

Group Type: ACTIVE_COMPARATOR

VSL#3 probiotic preparation

Intervention Type: DIETARY_SUPPLEMENT

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

30 mothers in the last 4 weeks of gestation and in the first month of breastfeeding will be given (after obtaining their informed consent) a placebo comparable to VSL#3 during the last four weeks of pregnancy and the first month of breastfeeding for four weeks under the usual fasting dosage scheme (1 sachet/day, before meal)

Group Type: PLACEBO_COMPARATOR

Placebo VSL#3

Intervention Type: OTHER

Placebo VSL#3 is a base of corn starch containing no active ingredient.

Interventions

VSL#3 probiotic preparation

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo VSL#3

Placebo VSL#3 is a base of corn starch containing no active ingredient.

Intervention Type: OTHER

Other Intervention Names

VSL#3; Placebo

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Policlinico Hospital

OTHER

Sponsor Role: lead

Responsible Party

Prof. Maria Elisabetta Baldassarre

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Elisabetta Baldassarre, PhD

Role: PRINCIPAL_INVESTIGATOR

Bari University

Locations

Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital

Bari, , Italy

to Be Confirmed

Bari, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32987448 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23078375 (View on PubMed)

Other Identifiers

486Baldassarre

Identifier Type: -

Identifier Source: org_study_id