NCT04032899.

Study name	Multicenter, randomised, 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
Methods	Quadruple‐blind RCT Setting: Spain
Participants	Target size: 480 participants Inclusion criteria: Normal development of pregnancy Single fetus pregnancy Within 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
Interventions	Intervention group: 1 capsule per day with L. fermentum CECT5716 3x109 CFU mixed with maltodextrins from week 28‐32 of gestation up to 16 weeks after delivery Control group (placebo): 1 capsule per day with maltodextrins from week 28‐32 of gestation up to 16 weeks after delivery
Outcomes	Incidence of mastitis, microbiota of breast milk, recurrence of mastitis, breast pain questionnaire, cessation of breastfeeding, percentage of infants who receive exclusive breastfeeding, immunoglobulins in breast milk, minerals in breast milk, baby faeces microbiota, incidence of caesareans and incidence of antibiotic use during delivery, baby's anthropometric measures, data about the intestinal health of the baby, data about sleep parameters of the baby All outcomes to be measured at 4 months
Starting date	April 15, 2019
Contact information	Principal Investigator: Nicolás Mendoza, MD, PhD
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