N/A
Completed N=40
Global Effects of a Probiotic Strain on Lactating Women
Source: ClinicalTrials.gov NCT01124448 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts — 3.09; 2.90 log10 CFU/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts |
3.09; 2.90 | — |
| SECONDARY Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples |
— | — |
| SECONDARY Evidence of Changes in the Metabolic Profile of Urine |
— | — |
| SECONDARY Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk |
— | — |
| SECONDARY Evidence of Changes in the Immunological Profile of Milk |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01124448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.