Clinical trial NCT04032899: Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastitis
Breast Milk
Lactation
Women's Health
Infant Health
Keywords: Probiotics
Gestation
Lactation
Mastitis
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2019-07-25
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of mastitis
timeFrame: 4 months
Secondary outcomes:
measure: Microbiota of breast milk
timeFrame: 4 months
Other outcomes:
measure: Recurrence of mastitis
timeFrame: 4 months
measure: Breast pain questionnaire
timeFrame: 4 months
measure: Time of Breastfeeding
timeFrame: 4 months
measure: Percentage of infants breastfeed
timeFrame: 4 months
measure: Measurement of biomarkers of inflammation in breast milk
timeFrame: 4 months
measure: Immunoglobulins in breast milk
timeFrame: 4 months
measure: Minerals in breast milk
timeFrame: 4 months
measure: Baby feces microbiota
timeFrame: 4 months
measure: Data on childbirth
timeFrame: 4 months
measure: Baby's anthropometric measures
timeFrame: 16 weeks
measure: Data about the intestinal health of the baby
timeFrame: 4 months
measure: Data about sleep parameters of the baby
timeFrame: 4 months
Locations:
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Andalucia
city: Granada
country: Spain
facility: Hospital Campus de la Salud
state: Grabada
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
Study officials:
affiliation: Professor of Gynecology at the Faculty of Medicine of the University of Granada
name: Nicolás Mendoza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.