An interventional study of Lactobacillus fermentum CECT5716 and Maltodextrin in Mastitis, Breast Milk and Lactation, sponsored by Biosearch S.A.. Completed at 3 sites in Spain. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Biosearch S.A. (part of Kerry Group plc) · Not applicable, Interventional, and Prevention
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.
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.
31 studies on the registry are indexed under Mastitis; 7 are open to participants now.
This study's enrollment of 480 is above the median of 114 across 16 interventional studies indexed under Mastitis.
Browse Mastitis studies →Biosearch S.A. is the lead sponsor of 23 studies on the registry; none are open to participants now.
First submitted before Biosearch S.A. became part of Kerry Group plc.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Dietary Supplement: Lactobacillus fermentum CECT5716
Volunteers will take 1 capsule per day with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery.
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.
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.
Incidence of mastitis
Total events during breastfeeding period /total number of participants
Time frame: 4 months
Microbiota of breast milk
Load of Staphylococcus, S. aureus, S. epidermidis, Streptococcus, Lactobacillus and L. fermentum CECT5716 in breast milk
Time frame: 4 months
Recurrence of mastitis
Reappearance of mastitis symptoms
Time frame: 4 months
Breast pain questionnaire
Mcgill Pain Questionnaire, validated for Spain. The Questionnaire has four dimensions or scales of measures of intensity: Sensory Intensity Value, Affective Intensity Value, Current Intensity Value, and Evaluative Intensity Value. The scales of the Questionnaire were calculated as the sum of their items. Those items were re-corded as 1 if the participant described the pain or as 0 if the participant did not report that type of pain. Thus, the sensory intensity scale can range from 0 to 33, as the full scale is formed by 33 items. The Affective scale varies from 0 to 19, and the scales of Current Intensity and Evaluative Intensity can range from 0 to 6 and 5, respectively
Time frame: 4 months
Time of Breastfeeding
Date of initiation and cessation of breastfeeding
Time frame: 4 months
Percentage of infants breastfeed
Percentage of infants who receive exclusive breastfeeding
Time frame: 4 months
Measurement of biomarkers of inflammation in breast milk
Concentration of IL-1b, IL-6, IL-8, IL-17, TNF-α in breast milk
Time frame: 4 months
Immunoglobulins in breast milk
Concentration of IgA, IgG1, IgG2, IgG3, IgG4 and IgM in breast milk
Time frame: 4 months
Minerals in breast milk
Concentration of calcium (μg/L), magnesium (μg/L) and potassium (μg/L) in breast milk
Time frame: 4 months
Baby feces microbiota
Presence of Escherichia coli, Clostridium, Bacteroides, Bifidobacteria, Lactobacillus and L. fermentum CECT5716 in baby feces
Time frame: 4 months
Data on childbirth
Incidence of cesareans and incidence of antibiotic use during delivery.
Time frame: 4 months
Baby's anthropometric measures
Anthropometric measures of the baby (weight in kg, height in cm and BMI in kg/m2) at birth, 4 weeks, 8 weeks and 16 weeks.
Time frame: 16 weeks
Data about the intestinal health of the baby
Data about stool frequency, colour and consistency of the feces and gasses
Time frame: 4 months
Data about sleep parameters of the baby
Hours of night sleeping per day and hours of total sleeping during the day
Time frame: 4 months
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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