Mastitis
Conditions
Brief summary
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.
Interventions
BIOLOGICALLactobacillus salivarius PS2
9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days
Sponsors
National Research Council, Spain
University of Valencia
Danone Global Research & Innovation Center
Universidad Complutense de Madrid
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts | one week | 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 |
Secondary
| Measure | 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 |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lactobacillus Salivarius PS2 Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)
Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days | 25 |
| Lactobacillus Salivarius PS2B Lactating women without mastitis (n=15)
Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days | 15 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Lactobacillus Salivarius PS2 | Lactobacillus Salivarius PS2B |
|---|---|---|---|
| Age, Continuous | 28.6 years STANDARD_DEVIATION 7.7 | 28.2 years STANDARD_DEVIATION 7.7 | 29.0 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment Spain | 40 participants | 25 participants | 15 participants |
| Sex: Female, Male Female | 40 Participants | 25 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Total milk bacterial count (initial) | 3.63 log10 CFU/mL STANDARD_DEVIATION 0.39 | 4.08 log10 CFU/mL STANDARD_DEVIATION 0.2 | 3.19 log10 CFU/mL STANDARD_DEVIATION 0.59 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 15 |
| serious Total, serious adverse events | 0 / 25 | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lactobacillus Salivarius PS2 | Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts | 3.09 log10 CFU/mL |
| Lactobacillus Salivarius PS2B | Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts | 2.90 log10 CFU/mL |
Secondary
Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples
Time frame: one year
Secondary
Evidence of Changes in the Immunological Profile of Milk
Time frame: one year
Secondary
Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk
Time frame: One year
Secondary
Evidence of Changes in the Metabolic Profile of Urine
Time frame: One year