<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/NCT03235635</url>
  </required_header>
  <id_info>
    <org_study_id>microbiome in nicu</org_study_id>
    <nct_id>NCT03235635</nct_id>
  </id_info>
  <brief_title>Metagenomic Analysis of Gut Microbiome in Preterm</brief_title>
  <acronym>MAGMP</acronym>
  <official_title>Metagenome Analysis of Intestinal Microbiome in Mortality and Morbidity of Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wonju Severance Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wonju Severance Christian Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is single center study. The investigators will try to know that relationships between&#xD;
      intestinal microbiome and mortality in preterm infants and what relationships is between&#xD;
      intestinal microbiome in preterm infants and morbidity, mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Microbiome is the collection of all the microorganisms living in association with the human&#xD;
      body which are consist of eukaryotes, archaea, bacteria and viruses. Microbiome in an average&#xD;
      human body number are ten times more than human cells and have about 1000 more genes than are&#xD;
      present in the human genome. There are symbiotic relationships between human and microbiome.&#xD;
      If investigators are able to know about relationships between newborn and intestinal&#xD;
      microbiome, mortality and morbidity in preterm infants may be improved. The investigators&#xD;
      will collect the first and weekly stool of participants and analyze DNA of microbiome&#xD;
      thorough Metagenomic anlysis. The results between 3 groups(preterm, late preterm and&#xD;
      full-term infants) will be compared. The investigators expect that a mean distribution of&#xD;
      intestinal microbiome in newborns(preterm, late preterm and full-term) is defined and that&#xD;
      relationships between mortality, morbidity and intestinal microbiome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Anticipated">February 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intestinal microbiome</measure>
    <time_frame>for 2 years</time_frame>
    <description>The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment which is one of the analysis in result of metagenomics in each infants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Full Enteral feeding in preterm infants</measure>
    <time_frame>for 2 years</time_frame>
    <description>Days to accomplish a full-enteral feeding in each infants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth rate</measure>
    <time_frame>for 2 years</time_frame>
    <description>Days to reach 2 kg of body weight in each infants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>for 2 years</time_frame>
    <description>Number of patients who died in neonatal intensive care unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>for 2 years</time_frame>
    <description>Number of patients who had a complication of preterm infants(e.g. necrotizing enterocolitis, bronchopulmonary dysplasia) or were died in neonatal intensive care unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allergic predisposition</measure>
    <time_frame>for 2 years</time_frame>
    <description>Number of patients who were developed a allergic predisposition at 6 month of postnatal age.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Microbial Colonization</condition>
  <condition>Microbial Superinvasion</condition>
  <condition>Microbial Substitution</condition>
  <condition>Newborn Morbidity</condition>
  <arm_group>
    <arm_group_label>Preterm</arm_group_label>
    <description>newborn infants were born with a gestational age of less than 32 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late preterm</arm_group_label>
    <description>newborn infants were born with a gestational age of greater than 32 weeks and less than 36 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>full-term</arm_group_label>
    <description>newborn infants were born with a gestational age of greater than or equal to 37 weeks</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      extraction microbiome DNA from stool of newborns&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        newborn infants who were born and admitted on neonatal intensive care unit of Wonju&#xD;
        Severance Christian Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preterm infants who were born at gestational age of less than 36 weeks from approval&#xD;
             date to Feb 28th 2019&#xD;
&#xD;
          -  full-term infants who were born at gestational age of greater than 37 weeks from&#xD;
             approval date to Feb 28th 2019&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  newborns with congenital anomaly&#xD;
&#xD;
          -  newborns with genetic syndrome&#xD;
&#xD;
          -  newborns without consent of parents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>1 Day</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Byoungkook Lee</last_name>
    <role>Study Chair</role>
    <affiliation>Wonju Severance Christian Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Byoungkook Lee</last_name>
    <phone>+82-10-6301-3067</phone>
    <email>raphael3067@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wonju Severance Christian Hospital</name>
      <address>
        <city>Wŏnju</city>
        <state>Gangwon-do</state>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Byoungkook Lee</last_name>
      <phone>+82-10-6301-3067</phone>
      <email>raphael3067@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Rautava S. Microbial Composition of the Initial Colonization of Newborns. Nestle Nutr Inst Workshop Ser. 2017;88:11-21. doi: 10.1159/000455209. Epub 2017 Mar 27.</citation>
    <PMID>28346920</PMID>
  </results_reference>
  <results_reference>
    <citation>Butel MJ, Suau A, Campeotto F, Magne F, Aires J, Ferraris L, Kalach N, Leroux B, Dupont C. Conditions of bifidobacterial colonization in preterm infants: a prospective analysis. J Pediatr Gastroenterol Nutr. 2007 May;44(5):577-82. doi: 10.1097/MPG.0b013e3180406b20.</citation>
    <PMID>17460489</PMID>
  </results_reference>
  <results_reference>
    <citation>Turnbaugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI. The human microbiome project. Nature. 2007 Oct 18;449(7164):804-10. doi: 10.1038/nature06244.</citation>
    <PMID>17943116</PMID>
  </results_reference>
  <results_reference>
    <citation>Jacquot A, Neveu D, Aujoulat F, Mercier G, Marchandin H, Jumas-Bilak E, Picaud JC. Dynamics and clinical evolution of bacterial gut microflora in extremely premature patients. J Pediatr. 2011 Mar;158(3):390-6. doi: 10.1016/j.jpeds.2010.09.007. Epub 2010 Oct 18.</citation>
    <PMID>20961563</PMID>
  </results_reference>
  <results_reference>
    <citation>Arboleya S, Binetti A, Salazar N, Fernandez N, Solis G, Hernandez-Barranco A, Margolles A, de Los Reyes-Gavilan CG, Gueimonde M. Establishment and development of intestinal microbiota in preterm neonates. FEMS Microbiol Ecol. 2012 Mar;79(3):763-72. doi: 10.1111/j.1574-6941.2011.01261.x. Epub 2011 Dec 15.</citation>
    <PMID>22126419</PMID>
  </results_reference>
  <results_reference>
    <citation>Johnson CL, Versalovic J. The human microbiome and its potential importance to pediatrics. Pediatrics. 2012 May;129(5):950-60. doi: 10.1542/peds.2011-2736. Epub 2012 Apr 2.</citation>
    <PMID>22473366</PMID>
  </results_reference>
  <results_reference>
    <citation>McElroy SJ, Weitkamp JH. Innate Immunity in the Small Intestine of the Preterm Infant. Neoreviews. 2011 Sep 1;12(9):e517-e526. doi: 10.1542/neo.12-9-e517.</citation>
    <PMID>22639551</PMID>
  </results_reference>
  <results_reference>
    <citation>Groer MW, Luciano AA, Dishaw LJ, Ashmeade TL, Miller E, Gilbert JA. Development of the preterm infant gut microbiome: a research priority. Microbiome. 2014 Oct 13;2:38. doi: 10.1186/2049-2618-2-38. eCollection 2014.</citation>
    <PMID>25332768</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 29, 2017</last_update_submitted>
  <last_update_submitted_qc>July 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wonju Severance Christian Hospital</investigator_affiliation>
    <investigator_full_name>Byoungkook Lee</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>microbiome</keyword>
  <keyword>preterm</keyword>
  <keyword>newborn</keyword>
  <keyword>gut microbiome</keyword>
  <keyword>allergic predisposition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Superinfection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Yes: There is a plan to make IPD and related data dictionaries available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>starting from august 2017 until February 2019</ipd_time_frame>
    <ipd_access_criteria>neonatology pediatrics infections</ipd_access_criteria>
  </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/NCT03235635
org study id: microbiome in nicu
nct id: NCT03235635
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is single center study. The investigators will try to know that relationships between
      intestinal microbiome and mortality in preterm infants and what relationships is between
      intestinal microbiome in preterm infants and morbidity, mortality.
Microbiome is the collection of all the microorganisms living in association with the human
      body which are consist of eukaryotes, archaea, bacteria and viruses. Microbiome in an average
      human body number are ten times more than human cells and have about 1000 more genes than are
      present in the human genome. There are symbiotic relationships between human and microbiome.
      If investigators are able to know about relationships between newborn and intestinal
      microbiome, mortality and morbidity in preterm infants may be improved. The investigators
      will collect the first and weekly stool of participants and analyze DNA of microbiome
      thorough Metagenomic anlysis. The results between 3 groups(preterm, late preterm and
      full-term infants) will be compared. The investigators expect that a mean distribution of
      intestinal microbiome in newborns(preterm, late preterm and full-term) is defined and that
      relationships between mortality, morbidity and intestinal microbiome.
observational model: Cohort
time perspective: Prospective
measure: Intestinal microbiome
time frame: for 2 years
description: The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment which is one of the analysis in result of metagenomics in each infants
measure: Full Enteral feeding in preterm infants
time frame: for 2 years
description: Days to accomplish a full-enteral feeding in each infants
measure: Growth rate
time frame: for 2 years
description: Days to reach 2 kg of body weight in each infants
measure: Mortality
time frame: for 2 years
description: Number of patients who died in neonatal intensive care unit.
measure: Morbidity
time frame: for 2 years
description: Number of patients who had a complication of preterm infants(e.g. necrotizing enterocolitis, bronchopulmonary dysplasia) or were died in neonatal intensive care unit.
measure: Allergic predisposition
time frame: for 2 years
description: Number of patients who were developed a allergic predisposition at 6 month of postnatal age.
arm group label: Preterm
description: newborn infants were born with a gestational age of less than 32 weeks
arm group label: Late preterm
description: newborn infants were born with a gestational age of greater than 32 weeks and less than 36 weeks
arm group label: full-term
description: newborn infants were born with a gestational age of greater than or equal to 37 weeks
extraction microbiome DNA from stool of newborns
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 1 Day
healthy volunteers: No
last name: Byoungkook Lee
role: Study Chair
affiliation: Wonju Severance Christian Hospital
last name: Byoungkook Lee
phone: +82-10-6301-3067
email: raphael3067@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Rautava S. Microbial Composition of the Initial Colonization of Newborns. Nestle Nutr Inst Workshop Ser. 2017;88:11-21. doi: 10.1159/000455209. Epub 2017 Mar 27.
PMID: 28346920
citation: Butel MJ, Suau A, Campeotto F, Magne F, Aires J, Ferraris L, Kalach N, Leroux B, Dupont C. Conditions of bifidobacterial colonization in preterm infants: a prospective analysis. J Pediatr Gastroenterol Nutr. 2007 May;44(5):577-82. doi: 10.1097/MPG.0b013e3180406b20.
PMID: 17460489
citation: Turnbaugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI. The human microbiome project. Nature. 2007 Oct 18;449(7164):804-10. doi: 10.1038/nature06244.
PMID: 17943116
citation: Jacquot A, Neveu D, Aujoulat F, Mercier G, Marchandin H, Jumas-Bilak E, Picaud JC. Dynamics and clinical evolution of bacterial gut microflora in extremely premature patients. J Pediatr. 2011 Mar;158(3):390-6. doi: 10.1016/j.jpeds.2010.09.007. Epub 2010 Oct 18.
PMID: 20961563
citation: Arboleya S, Binetti A, Salazar N, Fernandez N, Solis G, Hernandez-Barranco A, Margolles A, de Los Reyes-Gavilan CG, Gueimonde M. Establishment and development of intestinal microbiota in preterm neonates. FEMS Microbiol Ecol. 2012 Mar;79(3):763-72. doi: 10.1111/j.1574-6941.2011.01261.x. Epub 2011 Dec 15.
PMID: 22126419
citation: Johnson CL, Versalovic J. The human microbiome and its potential importance to pediatrics. Pediatrics. 2012 May;129(5):950-60. doi: 10.1542/peds.2011-2736. Epub 2012 Apr 2.
PMID: 22473366
citation: McElroy SJ, Weitkamp JH. Innate Immunity in the Small Intestine of the Preterm Infant. Neoreviews. 2011 Sep 1;12(9):e517-e526. doi: 10.1542/neo.12-9-e517.
PMID: 22639551
citation: Groer MW, Luciano AA, Dishaw LJ, Ashmeade TL, Miller E, Gilbert JA. Development of the preterm infant gut microbiome: a research priority. Microbiome. 2014 Oct 13;2:38. doi: 10.1186/2049-2618-2-38. eCollection 2014.
PMID: 25332768
responsible party type: Principal Investigator
investigator affiliation: Wonju Severance Christian Hospital
investigator full name: Byoungkook Lee
investigator title: assistant professor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Superinfection
sharing ipd: Yes
ipd description: Yes: There is a plan to make IPD and related data dictionaries available.
ipd info type: Study Protocol
ipd time frame: starting from august 2017 until February 2019
ipd access criteria: neonatology pediatrics infections