Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

Lactation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04032899
• Other study ID #: P045
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Biosearch S.A.
• Contact: Juristo Fonollá, PhD
• Phone: +34618738539
• Email: Juristo.FonollaJoya[@]biosearchlife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: November 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Campus de la Salud	Granada	Grabada
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital Costa del Sol	Marbella	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recurrence of mastitis	Reappearance of mastitis symptoms	4 months
Other	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	4 months
Other	Time of Breastfeeding	Date of initiation and cessation of breastfeeding	4 months
Other	Percentage of infants breastfeed	Percentage of infants who receive exclusive breastfeeding	4 months
Other	Measurement of biomarkers of inflammation in breast milk	Concentration of IL-1b, IL-6, IL-8, IL-17, TNF-a in breast milk	4 months
Other	Immunoglobulins in breast milk	Concentration of IgA, IgG1, IgG2, IgG3, IgG4 and IgM in breast milk	4 months
Other	Minerals in breast milk	Concentration of calcium (µg/L), magnesium (µg/L) and potassium (µg/L) in breast milk	4 months
Other	Baby feces microbiota	Presence of Escherichia coli, Clostridium, Bacteroides, Bifidobacteria, Lactobacillus and L. fermentum CECT5716 in baby feces	4 months
Other	Data on childbirth	Incidence of cesareans and incidence of antibiotic use during delivery.	4 months
Other	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.	16 weeks
Other	Data about the intestinal health of the baby	Data about stool frequency, colour and consistency of the feces and gasses	4 months
Other	Data about sleep parameters of the baby	Hours of night sleeping per day and hours of total sleeping during the day	4 months
Primary	Incidence of mastitis	Total events during breastfeeding period /total number of participants	4 months
Secondary	Microbiota of breast milk	Load of Staphylococcus, S. aureus, S. epidermidis, Streptococcus, Lactobacillus and L. fermentum CECT5716 in breast milk	4 months