Mastitis
Conditions
Keywords
mastitis, Staphylococcus, Streptococcus, lactation, breastfeeding
Brief summary
A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for 4 weeks. The three lactobacilli strains were originally isolated from milk of healthy women. On days 0 and 28, milk samples will be collected, and staphylococci/streptococci and lactobacilli will be counted and identified. Evolution of clinical signs will be recorded by midwifes on days 0, 7, 14 and 28.
Interventions
BIOLOGICALLactobacillus salivarius HN6
9 log colony-forming units, capsules, daily, four weeks
BIOLOGICALLactobacillus reuteri CR20
9 log colony-forming units, capsules, daily, four weeks
BIOLOGICALLactobacillus fermentum LC40
9 log colony-forming units, capsules, daily, four weeks
Use of amoxicillin, cloxacillin or amoxicillin/clavulanic acid(500-750 mg), orally, every 8-12 h, for 2-3 weeks (as prescribed by the physician responsible for the clinical diagnosis of lactational mastitis)
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of mastitis * Staphylococcal and/or streptococcal count higher than 3000 colony-forming units per ml of milk * Milk leukocyte count higher 6 log10/mL * Must be able to provide a milk sample without the aid of a milk pump
Exclusion criteria
* Mammary abscesses * Any kind of parallel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Staphylococcal and/or streptococcal count in milk | 0 and 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of local and systemic symptoms associated to mastitis | days 0, 7, 14 and 28 |
Countries
Spain
Outcome results
None listed