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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days
9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
Madrid, Madrid, Spain
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
Time frame: one week
Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples
Time frame: one year
Evidence of Changes in the Metabolic Profile of Urine
Time frame: One year
Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk
Time frame: One year
Evidence of Changes in the Immunological Profile of Milk
Time frame: one year
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