Global Effects of a Probiotic Strain on Lactating Women

Study Overview
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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.

Official Title
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Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects

Conditions
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Mastitis

Intervention / Treatment
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* Biological: Lactobacillus salivarius PS2
* Biological: Lactobacillus salivarius PS2


Participation Criteria
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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 Exclusion Criteria: Allergy to cow's milk protein Intolerance to lactose Antibiotic treatment Breast abscess Raynaud syndrome Any parallel disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus salivarius PS2<br>Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) | Biological: Lactobacillus salivarius PS2<br>* 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days<br>|
| Active Comparator: Lactobacillus salivarius PS2B<br>Lactating women without mastitis (n=15) | Biological: Lactobacillus salivarius PS2<br>* 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts | Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples |  | one year | 
| Evidence of Changes in the Metabolic Profile of Urine |  | One year | 
| Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk |  | One year | 
| Evidence of Changes in the Immunological Profile of Milk |  | one year |