Global Effects of a Probiotic Strain on Lactating Women

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-12-31

Brief Summary

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In this study, the investigators will try to confirm if application of probiotic strains isolated from breast milk actually have a beneficial effect on women suffering lactational mastitis. This project has been design to offer an integrated vision of the effects of probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators propose a multidisciplinary approach involving the application of microbiological, immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The hypothesis is that probiotherapy will cause different effects on the host, and the objective is the finding of markers that may support the beneficial effect of the strain in such condition.

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Detailed Description

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Conditions

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Mastitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lactobacillus salivarius PS2

Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)

Group Type EXPERIMENTAL

Lactobacillus salivarius PS2

Intervention Type BIOLOGICAL

9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days

Lactobacillus salivarius PS2B

Lactating women without mastitis (n=15)

Group Type ACTIVE_COMPARATOR

Lactobacillus salivarius PS2

Intervention Type BIOLOGICAL

9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days

Interventions

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Lactobacillus salivarius PS2

9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days

Intervention Type BIOLOGICAL

Lactobacillus salivarius PS2

9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Normal term pregnancy
* Lactating women
* Healthy breastfed infant

Women with mastitis:

* Clinical symptoms of mastitis
* Painful breastfeeding
* Count of staphylococci, streptococci and/or corynebacteria in milk higher than 3,000 colony-forming units/mL
* Leukocyte count in milk higher 6 log10/mL

Women without mastitis:

* No clinical symptoms of mastitis
* No painful breastfeeding
* Count of staphylococci, streptococci and/or corynebacteria in milk lower than 500 colony-forming units/mL
* Leukocyte count in milk lower 5 log10/mL