Multicenter, Randomized, Double-blind, Controlled Parallel Nutritional Intervention Study to Evaluate the Effect of Consumption During Pregnancy and the Lactation Period of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mastitis
- Sponsor
- Biosearch S.A.
- Enrollment
- 480
- Locations
- 3
- Primary Endpoint
- Incidence of mastitis
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis.
Bacterial load and immunological parameters in breast milk, parameters related to breastfeeding as well as health parameters of the mother and baby will also be evaluated.
Detailed Description
Pregnancy and lactation are important moments for the child that will determine their development and future health. One of the key processes is when the microbiota is established in the baby. Contamination during delivery with the mother's vaginal flora, as well as bacteria from the microbiota of breast milk, are important sources for intestinal colonization. However, the mother's microbiota can suffer alterations that affect the health of the mother and can also have an effect on the baby. Mastitis is a condition of the mammary gland that can affect between 3-30% of women during the period of lactation and is the first cause of abandonment of it. It is associated with a dysbiosis with the proliferation of microorganisms in milk such as Staphylococcus and Streptococcus. Previous studies carried out with the strain L. fermentum CECT5716 have demonstrated a powerful regulating activity of the microbiota of breast milk that translates into a preventive and curative effect on mastitis. The highest incidence of mastitis occurs during the first weeks after delivery, so the investigator's working hypothesis is that the modulation of the maternal microbiota before delivery would improve the effectiveness of the probiotic strain consumption.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Normal development of pregnancy
- •Single fetus pregnancy
- •Be in week 28-32 of pregnancy
- •Intention to breastfeed the child for 16 weeks
Exclusion Criteria
- •Having a breast disease that hinders or prevents breastfeeding
- •Have been taking probiotic supplements 2 weeks before starting the study
- •Have a low expectation of adherence to the study protocol
Outcomes
Primary Outcomes
Incidence of mastitis
Time Frame: 4 months
Total events during breastfeeding period /total number of participants
Secondary Outcomes
- Microbiota of breast milk(4 months)