NCT01367470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 15, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

3.7 years

First QC Date

April 15, 2011

Last Update Submit

January 9, 2014

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • Effect of VSL#3 probiotic administration on breast milk

    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.

    2 months

Secondary Outcomes (3)

  • Assessment of sphingomyelinase concentration in breastmilk of mothers

    2 months

  • Assessment of PAF hydrolysis in breastmilk of mothers

    2 months

  • Assessment of fecal newborn microbiota

    2 months

Study Arms (2)

VSL#3 probiotic preparation

ACTIVE COMPARATOR

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

Placebo VSL#3

PLACEBO COMPARATOR

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

Interventions

VSL#3 probiotic preparationDIETARY_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.

Also known as: VSL#3
VSL#3 probiotic preparation
Placebo VSL#3OTHER

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

Also known as: Placebo
Placebo VSL#3

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • over 18 years old
  • able to give informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Bari, 70124, Italy

Location

to Be Confirmed

Bari, Italy

Location

Related Publications (2)

  • 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.

    PMID: 32987448DERIVED

  • 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.

    PMID: 23078375DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Maria Elisabetta Baldassarre, PhD

    Bari University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

April 15, 2011

First Posted

June 7, 2011

Study Start

April 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

IT(2)