<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203877</url>
  </required_header>
  <id_info>
    <org_study_id>P032</org_study_id>
    <nct_id>NCT02203877</nct_id>
  </id_info>
  <brief_title>Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis</brief_title>
  <official_title>Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biosearch S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biosearch S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis&#xD;
      incidence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have demonstrated that L. fermentum CECT5716, a probiotic strain previously&#xD;
      isolated from breast milk, can be used as an effective treatment of mastitis and painful&#xD;
      breastfeeding by reducing pathogen counts in breast milk. This is a randomized double blinded&#xD;
      controlled study to evaluate the effect of L.fermentum CECT5716 on mastitis incidence and&#xD;
      Staphylococcus load in breast milk. Women will be recruited 1-6 days after child birth and&#xD;
      distributed into two groups: Probiotic group receiving 1 capsule/day containing L.fermentum&#xD;
      3x109cfu; Control group receiving 1 placebo capsule/day containing maltodextrin. The&#xD;
      intervention period is 16 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of mastitis</measure>
    <time_frame>up to 16 weeks</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluation of breast pain</measure>
    <time_frame>at times 0, 4, 8, 12 and 16 weeks</time_frame>
    <description>For pain evaluation a score from 1 (no pain) to 10 (extremely pain)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>microbiota breast milk</measure>
    <time_frame>at time 0 and 16 weeks</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>fecal microbiota of infants</measure>
    <time_frame>at 0 and 16 weeks</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>growth of infants</measure>
    <time_frame>at 0 and 16 weeeks</time_frame>
    <description>Weight, length and head circumference will be measured in infants at the beginning and at 16 weeks</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">625</enrollment>
  <condition>Mastitis</condition>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 capsule/day for 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lactobacillus fermentum CECT5716</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactobacillus fermentum CECT5716</intervention_name>
    <description>Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.</description>
    <arm_group_label>Lactobacillus fermentum CECT5716</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>Intervention with a daily capsule containing maltodextrin as placebo</description>
    <arm_group_label>Maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy women between 18 and 40 years with development of normal pregnancy Birth&#xD;
             between 37 and 42 weeks of gestation. Women who have received antibiotic treatment&#xD;
             between 48 hours before and 48 hours after childbirth (one dose is sufficient for&#xD;
             inclusion regardless of the type of antibiotic).&#xD;
&#xD;
        Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed&#xD;
        their children for at least 16 weeks..&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Mammary pathologies that hinder or preclude breastfeeding.&#xD;
&#xD;
          -  Low expectation of adherence to the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juristo Fonollá, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Biosearch S.A.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Virgen de las Nieves</name>
      <address>
        <city>Granada</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>August 11, 2016</last_update_submitted>
  <last_update_submitted_qc>August 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mastitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203877
org study id: P032
nct id: NCT02203877
lead sponsor: 
has dmc: No
To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis
      incidence.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: incidence of mastitis
time frame: up to 16 weeks
description: 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)
measure: evaluation of breast pain
time frame: at times 0, 4, 8, 12 and 16 weeks
description: For pain evaluation a score from 1 (no pain) to 10 (extremely pain)
measure: microbiota breast milk
time frame: at time 0 and 16 weeks
description: 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.
measure: fecal microbiota of infants
time frame: at 0 and 16 weeks
description: 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.
measure: growth of infants
time frame: at 0 and 16 weeeks
description: Weight, length and head circumference will be measured in infants at the beginning and at 16 weeks
arm group label: Maltodextrin
arm group type: Placebo Comparator
description: 1 capsule/day for 16 weeks
arm group label: Lactobacillus fermentum CECT5716
arm group type: Experimental
description: L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks
intervention type: Dietary Supplement
intervention name: Lactobacillus fermentum CECT5716
description: Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.
arm group label: Lactobacillus fermentum CECT5716
intervention type: Dietary Supplement
intervention name: Maltodextrin
description: Intervention with a daily capsule containing maltodextrin as placebo
arm group label: Maltodextrin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Juristo Fonollá, PhD
role: Study Chair
affiliation: Biosearch S.A.
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Mastitis
sharing ipd: No