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Completed

NCT Number: NCT04032899

Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

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.

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Key information

Conditions

Mastitis Behavior Breast Diseases Breast Feeding Breast Milk Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Infant Health Lactation Pregnancy Complications Puerperal Disorders Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Women's Health

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Costa del Sol, Marbella, Andalusia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus fermentum CECT5716

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Incidence of mastitis

    Time frame: 4 months

    Total events during breastfeeding period /total number of participants

Secondary outcomes

  1. Microbiota of breast milk

    Time frame: 4 months

    Load of Staphylococcus, S. aureus, S. epidermidis, Streptococcus, Lactobacillus and L. fermentum CECT5716 in breast milk

Other outcomes

  1. Recurrence of mastitis

    Time frame: 4 months

    Reappearance of mastitis symptoms

  2. Breast pain questionnaire

    Time frame: 4 months

    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

  3. Time of Breastfeeding

    Time frame: 4 months

    Date of initiation and cessation of breastfeeding

  4. Percentage of infants breastfeed

    Time frame: 4 months

    Percentage of infants who receive exclusive breastfeeding

  5. Measurement of biomarkers of inflammation in breast milk

    Time frame: 4 months

    Concentration of IL-1b, IL-6, IL-8, IL-17, TNF-α in breast milk

  6. Immunoglobulins in breast milk

    Time frame: 4 months

    Concentration of IgA, IgG1, IgG2, IgG3, IgG4 and IgM in breast milk

  7. Minerals in breast milk

    Time frame: 4 months

    Concentration of calcium (μg/L), magnesium (μg/L) and potassium (μg/L) in breast milk

  8. Baby feces microbiota

    Time frame: 4 months

    Presence of Escherichia coli, Clostridium, Bacteroides, Bifidobacteria, Lactobacillus and L. fermentum CECT5716 in baby feces

  9. Data on childbirth

    Time frame: 4 months

    Incidence of cesareans and incidence of antibiotic use during delivery.

  10. Baby's anthropometric measures

    Time frame: 16 weeks

    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.

  11. Data about the intestinal health of the baby

    Time frame: 4 months

    Data about stool frequency, colour and consistency of the feces and gasses

  12. Data about sleep parameters of the baby

    Time frame: 4 months

    Hours of night sleeping per day and hours of total sleeping during the day

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2019
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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