Breast Milk, Infant Health, Lactation, Mastitis, Women's Health
Conditions
Keywords
Probiotics, Gestation, Lactation, Mastitis
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus fermentum CECT5716
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits.
DIETARY_SUPPLEMENTMaltodextrin
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits.
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 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of mastitis | 4 months | Total events during breastfeeding period /total number of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota of breast milk | 4 months | Load of Staphylococcus, S. aureus, S. epidermidis, Streptococcus, Lactobacillus and L. fermentum CECT5716 in breast milk |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time of Breastfeeding | 4 months | Date of initiation and cessation of breastfeeding |
| Percentage of infants breastfeed | 4 months | Percentage of infants who receive exclusive breastfeeding |
| Measurement of biomarkers of inflammation in breast milk | 4 months | Concentration of IL-1b, IL-6, IL-8, IL-17, TNF-α in breast milk |
| Immunoglobulins in breast milk | 4 months | Concentration of IgA, IgG1, IgG2, IgG3, IgG4 and IgM in breast milk |
| Minerals in breast milk | 4 months | Concentration of calcium (μg/L), magnesium (μg/L) and potassium (μg/L) in breast milk |
| Recurrence of mastitis | 4 months | Reappearance of mastitis symptoms |
| Data on childbirth | 4 months | Incidence of cesareans and incidence of antibiotic use during delivery. |
| Baby's anthropometric measures | 16 weeks | Anthropometric measures of the baby (weight in kg, height in cm and BMI in kg/m2) at birth, 4 weeks, 8 weeks and 16 weeks. |
| Data about the intestinal health of the baby | 4 months | Data about stool frequency, colour and consistency of the feces and gasses |
| Data about sleep parameters of the baby | 4 months | Hours of night sleeping per day and hours of total sleeping during the day |
| Baby feces microbiota | 4 months | Presence of Escherichia coli, Clostridium, Bacteroides, Bifidobacteria, Lactobacillus and L. fermentum CECT5716 in baby feces |
| Breast pain questionnaire | 4 months | Mcgill Pain Questionnaire, validated for Spain. The Questionnaire has four dimensions or scales of measures of intensity: Sensory Intensity Value, Affective Intensity Value, Current Intensity Value, and Evaluative Intensity Value. The scales of the Questionnaire were calculated as the sum of their items. Those items were re-corded as 1 if the participant described the pain or as 0 if the participant did not report that type of pain. Thus, the sensory intensity scale can range from 0 to 33, as the full scale is formed by 33 items. The Affective scale varies from 0 to 19, and the scales of Current Intensity and Evaluative Intensity can range from 0 to 6 and 5, respectively |
Countries
Spain
Outcome results
None listed