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Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

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ClinicalTrials.gov Identifier: NCT02203877
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Biosearch S.A.

Tracking Information
First Submitted Date  ICMJE July 29, 2014
First Posted Date  ICMJE July 30, 2014
Last Update Posted Date August 12, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2014)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
incidence of mastitis [ Time Frame: up to 16 weeks ]
Change History Complete list of historical versions of study NCT02203877 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2014)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
evaluation of breast pain [ Time Frame: at times 0, 4, 8, 12 and 16 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: July 30, 2014)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: July 29, 2014)
  • microbiota breast milk [ Time Frame: at time 0 and 16 weeks ]
  • fecal microbiota of infants [ Time Frame: at 0 and 16 weeks ]
  • growth of infants [ Time Frame: at 0 and 16 weeeks ]
 
Descriptive Information
Brief Title  ICMJE Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
Official Title  ICMJE Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis
Brief Summary To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Mastitis
Intervention  ICMJE
  • Dietary Supplement: Lactobacillus fermentum CECT5716
    Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.
  • Dietary Supplement: Maltodextrin
    Intervention with a daily capsule containing maltodextrin as placebo
Study Arms  ICMJE
  • Placebo Comparator: Maltodextrin
    1 capsule/day for 16 weeks
    Intervention: Dietary Supplement: Maltodextrin
  • Experimental: Lactobacillus fermentum CECT5716
    L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks
    Intervention: Dietary Supplement: Lactobacillus fermentum CECT5716
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2016)
625
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2014)
600
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02203877
Other Study ID Numbers  ICMJE P032
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biosearch S.A.
Study Sponsor  ICMJE Biosearch S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Juristo Fonollá, PhD Biosearch S.A.
PRS Account Biosearch S.A.
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP