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

NCT01367470 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2014-01-10

No results posted yet for this study

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.

Conditions

  • Allergy

Interventions

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

Placebo VSL#3

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

Sponsors & Collaborators

  • Policlinico Hospital

    lead OTHER

Principal Investigators

  • Maria Elisabetta Baldassarre, PhD · Bari University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01367470 on ClinicalTrials.gov