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Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosearch S.A.
ClinicalTrials.gov Identifier:
NCT02203877
First received: July 29, 2014
Last updated: August 11, 2016
Last verified: July 2014
  Purpose
To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.

Condition Intervention
Mastitis Dietary Supplement: Lactobacillus fermentum CECT5716 Dietary Supplement: Maltodextrin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis

Resource links provided by NLM:


Further study details as provided by Biosearch S.A.:

Primary Outcome Measures:
  • incidence of mastitis [ Time Frame: up to 16 weeks ]
    mastitis was defined as at least two out of the three breast symptoms (pain, redness, lump) and at least one of fever or flu-like symptoms (shivering, hot sweats or aches)


Secondary Outcome Measures:
  • evaluation of breast pain [ Time Frame: at times 0, 4, 8, 12 and 16 weeks ]
    For pain evaluation a score from 1 (no pain) to 10 (extremely pain)


Other Outcome Measures:
  • microbiota breast milk [ Time Frame: at time 0 and 16 weeks ]
    DNA will be extracted from breast milk samples. Staphylococcus genus, Streptococcus and Lactobacillus will be evaluated by qPCR with specific probes designed to quantify these bacterial genus.

  • fecal microbiota of infants [ Time Frame: at 0 and 16 weeks ]
    DNA will be extracted from infant´s feces samples. Lactobacillus, bifidobacterium, clostridium, bacteroides will be evaluated by qPCR with specific probes designed to quantify these bacterial genus.

  • growth of infants [ Time Frame: at 0 and 16 weeeks ]
    Weight, length and head circumference will be measured in infants at the beginning and at 16 weeks


Enrollment: 625
Study Start Date: August 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Maltodextrin
1 capsule/day for 16 weeks
Dietary Supplement: Maltodextrin
Intervention with a daily capsule containing maltodextrin as placebo
Experimental: Lactobacillus fermentum CECT5716
L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks
Dietary Supplement: Lactobacillus fermentum CECT5716
Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.

Detailed Description:
Previous studies have demonstrated that L. fermentum CECT5716, a probiotic strain previously isolated from breast milk, can be used as an effective treatment of mastitis and painful breastfeeding by reducing pathogen counts in breast milk. This is a randomized double blinded controlled study to evaluate the effect of L.fermentum CECT5716 on mastitis incidence and Staphylococcus load in breast milk. Women will be recruited 1-6 days after child birth and distributed into two groups: Probiotic group receiving 1 capsule/day containing L.fermentum 3x109cfu; Control group receiving 1 placebo capsule/day containing maltodextrin. The intervention period is 16 weeks.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women between 18 and 40 years with development of normal pregnancy Birth between 37 and 42 weeks of gestation. Women who have received antibiotic treatment between 48 hours before and 48 hours after childbirth (one dose is sufficient for inclusion regardless of the type of antibiotic).

Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed their children for at least 16 weeks..

Exclusion Criteria:

  • - Mammary pathologies that hinder or preclude breastfeeding.
  • Low expectation of adherence to the study protocol.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02203877

Locations
Spain
Hospital Virgen de las Nieves
Granada, Spain
Sponsors and Collaborators
Biosearch S.A.
Investigators
Study Chair: Juristo Fonollá, PhD Biosearch S.A.
  More Information

Responsible Party: Biosearch S.A.
ClinicalTrials.gov Identifier: NCT02203877     History of Changes
Other Study ID Numbers: P032
Study First Received: July 29, 2014
Last Updated: August 11, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Mastitis
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 26, 2017