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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT01367470
First received: April 15, 2011
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Allergy
Dietary Supplement: VSL#3 probiotic preparation
Other: Placebo VSL#3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:
  • Effect of VSL#3 probiotic administration on breast milk [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Assessment of the effects of administration of a probiotic in the last four weeks of gestation and/or during the first month of lactation on the breast milk concentrations of cytokines (TGF-beta, IL-6, IL-10) and immunoglobulines (IGG, IGA, IGM) as well as metabolic profiles and the amount of probiotic species. A total of 30 mothers per arm is expected to be enrolled in the study. Interim analysis will be conducted upon completion of 9 patients per arm.


Secondary Outcome Measures:
  • Assessment of sphingomyelinase concentration in breastmilk of mothers [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Assessment of PAF hydrolysis in breastmilk of mothers [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Assessment of fecal newborn microbiota [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: April 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Dietary Supplement: 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.
Other Name: VSL#3
Placebo Comparator: 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)
Other: Placebo VSL#3
Placebo VSL#3 is a base of corn starch containing no active ingredient.
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • over 18 years old
  • able to give informed consent

Exclusion Criteria:

  • twin pregnancies, pregnancy diseases (threat of miscarriage, maternal chronic conditions)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367470

Locations
Italy
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, Italy, 70124
to Be Confirmed
Bari, Italy
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Maria Elisabetta Baldassarre, PhD Bari University
  More Information

No publications provided by Policlinico Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Maria Elisabetta Baldassarre, Professor of Pediatrics, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT01367470     History of Changes
Other Study ID Numbers: 486Baldassarre
Study First Received: April 15, 2011
Last Updated: January 9, 2014
Health Authority: Direttore Generale dell'Azienda Ospedaliero-Universitaria Ospedale Consorziale Policlinico Bari Italy':'

ClinicalTrials.gov processed this record on September 15, 2014