Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

Biosearch Life

Status: Enrolling

Conditions: Infant Health; Women's Health; Breast Milk; Lactation; Mastitis

Treatments: Dietary Supplement: Lactobacillus fermentum CECT5716; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04032899

P045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 2 patient groups, including a placebo group

L. fermentum CECT5716 3x109 ufc

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lactobacillus fermentum CECT5716

Maltodextrin

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Maltodextrin