Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Mastitis, Breast Milk, Lactation, Women's Health, Infant Health

Intervention / Treatment
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* Dietary Supplement: Lactobacillus fermentum CECT5716
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L. fermentum CECT5716 3x109 ufc<br>Volunteers will take 1 capsule per day with L. fermentum CECT5716 3x109 cfu mixed with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery. | Dietary Supplement: Lactobacillus fermentum CECT5716<br>* 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.<br>|
| Placebo Comparator: Maltodextrin<br>Volunteers will take 1 capsule per day with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery. | Dietary Supplement: Maltodextrin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of mastitis | Total events during breastfeeding period /total number of participants | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota of breast milk | Load of Staphylococcus, S. aureus, S. epidermidis, Streptococcus, Lactobacillus and L. fermentum CECT5716 in breast milk | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Gestation, Lactation, Mastitis