<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/NCT02192996</url>
  </required_header>
  <id_info>
    <org_study_id>HULP3551</org_study_id>
    <secondary_id>Universidad Complutense Madrid</secondary_id>
    <nct_id>NCT02192996</nct_id>
  </id_info>
  <brief_title>Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight Preterm, a Pilot Study</brief_title>
  <official_title>Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight, a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Paz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Complutense de Madrid</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitario La Paz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot trial is designed to investigate the benefits of the use of probiotics in GUT&#xD;
      microbiota development and/or immunological biomarkers and how this can be related with the&#xD;
      clinical status of very low birth weight preterms during their first weeks of life at the&#xD;
      neonatal intensive care unit(NICU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot trial is designed to investigate the benefits of the use of mixtures of probiotics&#xD;
      isolated from human milk in GUT microbiota development and/or immunological biomarkers.&#xD;
      Furthermore, the relationship between evaluated parameters and the clinical status of very&#xD;
      low birth weight preterms during their first weeks of life at the NICU will be analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in microbiological counts in feces of preterm infants</measure>
    <time_frame>prior to initiate and at 7th, 14th, 21th, 28th days receiving probiotics</time_frame>
    <description>Adequate dilutions of meconium and stool samples were spread onto general and selective culture media for the enumeration of different bacterial species. Identification of isolates was carried out by matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>concentration of immunological parameters on feces</measure>
    <time_frame>prior to star and at 7th, 14th and 21st days of receiving probiotics</time_frame>
    <description>multiplex methodology and enzyme-Linked ImmunoSorbent Assay (ELISA) were used to determine a wide range of immune compounds and calprotectin as immune system status biomarkers: immunoglobulin(Ig) G1, IgG2, IgG3, IgG4, IgM, IgA, interleukin (IL)-1b, IL-6, IL-12,interferon-gamma, Tumor necrosis factor-alpha,IL-2,IL-4,IL-10, IL-13, IL-17, IL-8, growth related oncogene- alpha, macrophages chemoattractant protein-1, macrophage inflammatory protein-1b, IL-5, IL-7, granulocytemacrophage -colony stimulating factor (GM-CSF), granulocyte-colony stimulating factor (G-CSF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concentration of immunological parameters on plasma samples</measure>
    <time_frame>7th, 14th, 19th and 24th days of receiving probiotic).</time_frame>
    <description>multiplex methodology and enzyme-Linked ImmunoSorbent Assay (ELISA) were used to determine a wide range of immune compounds and calprotectin as immune system status biomarkers: immunoglobulin(Ig) G1, IgG2, IgG3, IgG4, IgM, IgA, interleukin (IL)-1b, IL-6, IL-12,interferon-gamma, Tumor necrosis factor-alpha,IL-2,IL-4,IL-10, IL-13, IL-17, IL-8, growth related oncogene- alpha, macrophages chemoattractant protein-1, macrophage inflammatory protein-1b, IL-5, IL-7, granulocytemacrophage -colony stimulating factor (GM-CSF), granulocyte-colony stimulating factor (G-CSF).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>clinical features during NICU stay</measure>
    <time_frame>during NICU stay, arround 1 moth</time_frame>
    <description>medical staff registered all the clinical status of the enrolled infants, after that the most relevant morbidity parameters associated to prematurity were factorized and evaluated by the clinicians, prior to evaluate the possible relationships with the other outcomes measured.&#xD;
-Necrotizing enterocolitis, late onset sepsis, intestinal motility evaluated by feeding tolerance and determination ot total gastrointestinal transit time by the administration of carmin red, type of feeding, respiratory support, intraventricular hemorrhage. Describe healthy status of each preterm</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Other Preterm Infants</condition>
  <condition>NEC</condition>
  <arm_group>
    <arm_group_label>Probiotics supplementation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Five very low birth weight (VLBW) infants enrolled within 2 days of birth, with a weight &lt; 1300 g and gestational age &lt; 29 weeks and without any malformation or metabolic disease at birth were supplemented with two daily doses of a mixture of &quot;Bifidobacterium breve&quot; and &quot;Lactobacillus salivarius&quot; , probiotic strains isolated from human milk during their first weeks of life. The lyophilized powder has contained at least 1x10^9 colony forming units (CFU) per doses of each one of the probiotic bacteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>blood and fecal samples were collected from five VLBW preterms which were supplemented with a probiotic mixture of Bifidobacterium breve / Lactobacillus salivarius isolated from human milk</description>
    <arm_group_label>Probiotics supplementation</arm_group_label>
    <other_name>&quot;Bifidobacterium breve / Lactobacillus salivarius mixture&quot;</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preterm infants with birth weight less than one thousand and three hundred grammes&#xD;
&#xD;
          -  preterm infants with gestational age less than 29 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mayor malformations&#xD;
&#xD;
          -  chromosomopathies&#xD;
&#xD;
          -  congenital infections&#xD;
&#xD;
          -  non parental consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>1 Week</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miguel Saenz de Pipaon, PhD. MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario La Paz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Paz</investigator_affiliation>
    <investigator_full_name>Esperanza Escribano</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <keyword>VLBW preterm</keyword>
  <keyword>GUT microbiota</keyword>
  <keyword>probiotics supplementation</keyword>
  <keyword>immune compounds</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Birth Weight</mesh_term>
  </condition_browse>
  <!-- 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/NCT02192996
org study id: HULP3551
secondary id: Universidad Complutense Madrid
nct id: NCT02192996
lead sponsor: 
collaborator: 
has dmc: No
This pilot trial is designed to investigate the benefits of the use of probiotics in GUT
      microbiota development and/or immunological biomarkers and how this can be related with the
      clinical status of very low birth weight preterms during their first weeks of life at the
      neonatal intensive care unit(NICU).
This pilot trial is designed to investigate the benefits of the use of mixtures of probiotics
      isolated from human milk in GUT microbiota development and/or immunological biomarkers.
      Furthermore, the relationship between evaluated parameters and the clinical status of very
      low birth weight preterms during their first weeks of life at the NICU will be analysed.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: changes in microbiological counts in feces of preterm infants
time frame: prior to initiate and at 7th, 14th, 21th, 28th days receiving probiotics
description: Adequate dilutions of meconium and stool samples were spread onto general and selective culture media for the enumeration of different bacterial species. Identification of isolates was carried out by matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry.
measure: concentration of immunological parameters on feces
time frame: prior to star and at 7th, 14th and 21st days of receiving probiotics
description: multiplex methodology and enzyme-Linked ImmunoSorbent Assay (ELISA) were used to determine a wide range of immune compounds and calprotectin as immune system status biomarkers: immunoglobulin(Ig) G1, IgG2, IgG3, IgG4, IgM, IgA, interleukin (IL)-1b, IL-6, IL-12,interferon-gamma, Tumor necrosis factor-alpha,IL-2,IL-4,IL-10, IL-13, IL-17, IL-8, growth related oncogene- alpha, macrophages chemoattractant protein-1, macrophage inflammatory protein-1b, IL-5, IL-7, granulocytemacrophage -colony stimulating factor (GM-CSF), granulocyte-colony stimulating factor (G-CSF).
measure: concentration of immunological parameters on plasma samples
time frame: 7th, 14th, 19th and 24th days of receiving probiotic).
description: multiplex methodology and enzyme-Linked ImmunoSorbent Assay (ELISA) were used to determine a wide range of immune compounds and calprotectin as immune system status biomarkers: immunoglobulin(Ig) G1, IgG2, IgG3, IgG4, IgM, IgA, interleukin (IL)-1b, IL-6, IL-12,interferon-gamma, Tumor necrosis factor-alpha,IL-2,IL-4,IL-10, IL-13, IL-17, IL-8, growth related oncogene- alpha, macrophages chemoattractant protein-1, macrophage inflammatory protein-1b, IL-5, IL-7, granulocytemacrophage -colony stimulating factor (GM-CSF), granulocyte-colony stimulating factor (G-CSF).
measure: clinical features during NICU stay
time frame: during NICU stay, arround 1 moth
description: medical staff registered all the clinical status of the enrolled infants, after that the most relevant morbidity parameters associated to prematurity were factorized and evaluated by the clinicians, prior to evaluate the possible relationships with the other outcomes measured.
-Necrotizing enterocolitis, late onset sepsis, intestinal motility evaluated by feeding tolerance and determination ot total gastrointestinal transit time by the administration of carmin red, type of feeding, respiratory support, intraventricular hemorrhage. Describe healthy status of each preterm
arm group label: Probiotics supplementation
arm group type: Other
description: Five very low birth weight (VLBW) infants enrolled within 2 days of birth, with a weight < 1300 g and gestational age < 29 weeks and without any malformation or metabolic disease at birth were supplemented with two daily doses of a mixture of "Bifidobacterium breve" and "Lactobacillus salivarius" , probiotic strains isolated from human milk during their first weeks of life. The lyophilized powder has contained at least 1x10^9 colony forming units (CFU) per doses of each one of the probiotic bacteria.
intervention type: Dietary Supplement
intervention name: Probiotic
description: blood and fecal samples were collected from five VLBW preterms which were supplemented with a probiotic mixture of Bifidobacterium breve / Lactobacillus salivarius isolated from human milk
arm group label: Probiotics supplementation
other name: "Bifidobacterium breve / Lactobacillus salivarius mixture"
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 1 Week
healthy volunteers: No
last name: Miguel Saenz de Pipaon, PhD. MD.
role: Principal Investigator
affiliation: Hospital Universitario La Paz
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Paz
investigator full name: Esperanza Escribano
investigator title: Medical doctor
mesh term: Premature Birth
mesh term: Birth Weight