NCT04032899

Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Biosearch S.A. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mastitis
• Breast Milk
• Lactation
• Women's Health
• Infant Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
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.

Timeline

• Start date: 2019-04-15
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2019-07-25
• Last updated: 2025-02-06

Locations

3 sites across 1 country: Spain