Clinical Trial: L.Fermentum CECT5716 in Treatment of Breast Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of Intervention Nutritional, Multicenter, Randomized, Blind, Parallel Group to Evaluate the Efficacy of Lactobacillus Fermentum CECT5716 to Reduce the Load Bacterial in Potential Pathogens in Mi

Brief Summary: The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women with breast pain

Detailed Summary:

  1. Type of study Nutritional intervention study, multicenter, randomized, blinded, parallel group included 25 women per group

    • Group 1: 3x109 cfu / day (n = 25)
    • Group 2: 6x109 cfu / day (n = 25)
    • Group 3: 9x109 cfu / day (n = 25)
    • Group 4: placebo (n = 25)
  2. Statistical calculation of sample size. The calculation of sample size was calculated by the company SEPLIN Solutions Statistics. The primary endpoint was the bacterial count of in milk. The sample size obtained to observe a difference of 1 log10, with a power of 0.80 and a significance level of 0.05 was 20 volunteers per group.

  3. Randomization Randomization was performed using a list of random numbers generated by computer. Subjects will be randomized in a strictly sequential.

    If a subject is removed from the test, the number that was assigned randomization not be reused again.

  4. Overall design and outline of the study At visit 1 we require the informed consent of the patient. It will take the milk sample, we will review the implementation of the inclusion and exclusion criteria. Be randomized and explain the treatment guidelines to be followed, the data to be collected and medical appointments that must go (2 and 3 weeks). It will complete the pain assessment questionnaire (MQP) and nutrition survey.

    On visits 2, 3 and 4 corresponding to 1, 2 and 3 weeks of intervention will collect milk sample pain assess
    Sponsor: Biosearch S.A.

    Current Primary Outcome: Change from baseline Staphylococcus count at 3 weeks [ Time Frame: 0, 3 weeks ]

    Counts of Staphylococcus in breast milk


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change from baseline Streptococcus counts at 3 weeks [ Time Frame: 0, 3 weeks ]
      Streptococcus counts in breast milk
    • Change from Breast pain score at 3 weeks [ Time Frame: 0, 3 weeks ]
      evaluation of breast pain


    Original Secondary Outcome: Same as current

    Information By: Biosearch S.A.

    Dates:
    Date Received: July 18, 2013
    Date Started: July 2011
    Date Completion:
    Last Updated: March 19, 2014
    Last Verified: March 2014