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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

April 15, 2011
January 9, 2014
April 2010
December 2013   (final data collection date for primary outcome measure)
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.
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). 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.
Complete list of historical versions of study NCT01367470 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Influence of Probiotic VSL#3 Administration on Metabolic and Immunological Profile of the Milk of Breastfeeding Mothers
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Allergy
  • 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
  • Other: Placebo VSL#3
    Placebo VSL#3 is a base of corn starch containing no active ingredient.
    Other Name: Placebo
  • 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).
    Intervention: Dietary Supplement: VSL#3 probiotic preparation
  • 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)
    Intervention: Other: Placebo VSL#3
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • over 18 years old
  • able to give informed consent

Exclusion Criteria:

  • twin pregnancies, pregnancy diseases (threat of miscarriage, maternal chronic conditions)
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01367470
486Baldassarre
Yes
Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
Policlinico Hospital
Not Provided
Principal Investigator: Maria Elisabetta Baldassarre, PhD Bari University
Policlinico Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP