Mastitis
Conditions
Brief summary
To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.
Detailed description
Previous studies have demonstrated that L. fermentum CECT5716, a probiotic strain previously isolated from breast milk, can be used as an effective treatment of mastitis and painful breastfeeding by reducing pathogen counts in breast milk. This is a randomized double blinded controlled study to evaluate the effect of L.fermentum CECT5716 on mastitis incidence and Staphylococcus load in breast milk. Women will be recruited 1-6 days after child birth and distributed into two groups: Probiotic group receiving 1 capsule/day containing L.fermentum 3x109cfu; Control group receiving 1 placebo capsule/day containing maltodextrin. The intervention period is 16 weeks.
Interventions
DIETARY_SUPPLEMENTLactobacillus fermentum CECT5716
Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.
DIETARY_SUPPLEMENTMaltodextrin
Intervention with a daily capsule containing maltodextrin as placebo
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy women between 18 and 40 years with development of normal pregnancy Birth between 37 and 42 weeks of gestation. Women who have received antibiotic treatment between 48 hours before and 48 hours after childbirth (one dose is sufficient for inclusion regardless of the type of antibiotic). Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed their children for at least 16 weeks..
Exclusion criteria
* \- Mammary pathologies that hinder or preclude breastfeeding. * Low expectation of adherence to the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of mastitis | up to 16 weeks | mastitis was defined as at least two out of the three breast symptoms (pain, redness, lump) and at least one of fever or flu-like symptoms (shivering, hot sweats or aches) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of breast pain | at times 0, 4, 8, 12 and 16 weeks | For pain evaluation a score from 1 (no pain) to 10 (extremely pain) |
Other
| Measure | Time frame | Description |
|---|---|---|
| microbiota breast milk | at time 0 and 16 weeks | DNA will be extracted from breast milk samples. Staphylococcus genus, Streptococcus and Lactobacillus will be evaluated by qPCR with specific probes designed to quantify these bacterial genus. |
| fecal microbiota of infants | at 0 and 16 weeks | DNA will be extracted from infant´s feces samples. Lactobacillus, bifidobacterium, clostridium, bacteroides will be evaluated by qPCR with specific probes designed to quantify these bacterial genus. |
| growth of infants | at 0 and 16 weeeks | Weight, length and head circumference will be measured in infants at the beginning and at 16 weeks |
Countries
Spain
Outcome results
None listed