Status:
COMPLETED
Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
Lead Sponsor:
Biosearch S.A.
Conditions:
Mastitis
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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
- \- Mammary pathologies that hinder or preclude breastfeeding.
- Low expectation of adherence to the study protocol.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
625 Patients enrolled
Trial Details
Trial ID
NCT02203877
Start Date
August 1 2013
End Date
August 1 2015
Last Update
August 12 2016
Active Locations (1)
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1
Hospital Virgen de las Nieves
Granada, Granada, Spain