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Trial record 15 of 99 for:    Lactobacillus | maltodextrin

Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

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ClinicalTrials.gov Identifier: NCT04032899
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04032899


Contacts
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Contact: Juristo Fonollá, PhD +34618738539 Juristo.FonollaJoya@biosearchlife.com

Locations
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Spain
Hospital Costa del Sol Recruiting
Marbella, Andalucia, Spain, 29603
Contact: Mª Caridad Ortiz       mcaridad.ortiz@gmail.com   
Hospital Campus de la Salud Recruiting
Granada, Grabada, Spain, 18007
Contact: Raquel Rodríguez       raquel.rodriguez.blanque.sspa@juntadeandalucia.es   
Hospital Virgen de las Nieves Recruiting
Granada, Spain, 18014
Contact: Carmen Ariza       maricarmen_ariza@yahoo.es   
Principal Investigator: Carmen ARiza         
Sponsors and Collaborators
Biosearch S.A.
Investigators
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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.
ClinicalTrials.gov Identifier: NCT04032899     History of Changes
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.:
Probiotics
Gestation
Lactation
Mastitis
Additional relevant MeSH terms:
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Mastitis
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases