Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

Not Applicable

Completed

• Conditions: Lactation; Women's Health; Infant Health; Mastitis; Breast Milk
• Interventions: Dietary Supplement: Lactobacillus fermentum CECT5716; Dietary Supplement: Maltodextrin

• Registration Number: NCT04032899
• Lead Sponsor: Biosearch S.A.

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.

Study Timeline

• Study Start: 2019-04-15
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-25
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L. fermentum CECT5716 3x109 ufc	Lactobacillus fermentum CECT5716	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.
Maltodextrin	Maltodextrin	Volunteers will take 1 capsule per day with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery.

Primary Outcome Measures

Name	Time	Method
Incidence of mastitis	4 months	Total events during breastfeeding period /total number of participants

Secondary Outcome Measures

Name	Time	Method
Microbiota of breast milk	4 months	Load of Staphylococcus, S. aureus, S. epidermidis, Streptococcus, Lactobacillus and L. fermentum CECT5716 in breast milk

Trial Locations

Locations (3)

Hospital Costa del Sol; 🇪🇸 Marbella, Andalucia, Spain

Hospital Campus de la Salud; 🇪🇸 Granada, Grabada, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain