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Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04032899
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Information provided by (Responsible Party):
Biosearch S.A.

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.

Condition or disease Intervention/treatment Phase
Mastitis Breast Milk Lactation Women's Health Infant Health Dietary Supplement: Lactobacillus fermentum CECT5716 Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: L. fermentum CECT5716 3x109 ufc
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
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.

Placebo Comparator: Maltodextrin
Volunteers will take 1 capsule per day with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery.
Dietary Supplement: Placebo
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 Outcome Measures :
  1. Incidence of mastitis [ Time Frame: 4 months ]
    Total events during breastfeeding period /total number of participants

Secondary Outcome Measures :
  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 Outcome Measures:
  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: 4 months ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04032899

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Contact: Juristo Fonollá, PhD +34618738539

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Hospital Costa del Sol Recruiting
Marbella, Andalucia, Spain, 29603
Contact: Mª Caridad Ortiz   
Hospital Campus de la Salud Recruiting
Granada, Grabada, Spain, 18007
Contact: Raquel Rodríguez   
Hospital Virgen de las Nieves Recruiting
Granada, Spain, 18014
Contact: Carmen Ariza   
Principal Investigator: Carmen ARiza         
Sponsors and Collaborators
Biosearch S.A.
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Principal Investigator: Nicolás Mendoza, MD, PhD Professor of Gynecology at the Faculty of Medicine of the University of Granada

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Responsible Party: Biosearch S.A. Identifier: NCT04032899    
Other Study ID Numbers: P045
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biosearch S.A.:
Additional relevant MeSH terms:
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Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases