Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2024-05-31

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.

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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.

Conditions

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Mastitis Breast Milk Lactation Women's Health Infant Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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L. fermentum CECT5716 3x109 ufc

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.

Group Type EXPERIMENTAL

Lactobacillus fermentum CECT5716

Intervention Type DIETARY_SUPPLEMENT

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.

Maltodextrin

Volunteers will take 1 capsule per day with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Lactobacillus 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.

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

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.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes