<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/NCT04420507</url>
  </required_header>
  <id_info>
    <org_study_id>Gut and oral microbiome of GDM</org_study_id>
    <nct_id>NCT04420507</nct_id>
  </id_info>
  <brief_title>Gut and Oral Microbiome of GDM Patients During Pregnancy</brief_title>
  <official_title>Different Characteristics of Gut and Oral Microbiota of Women With Gestational Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The study aimed to clarify the characteristics of the intestinal and oral microbiome of&#xD;
      Gestational Diabetes Mellitus(GDM) patients during the whole pregnancy, try to clarify the&#xD;
      relationship between the microbiome and GDM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims of the study are to reveal the possibly natural change of the gut and oral&#xD;
      microbiome of GDM patients during pregnancy, and to explorer whether GDM happened during&#xD;
      pregnancy are associated with the maternal gut and oral microbiomes. As a perspective cohort&#xD;
      study, the researchers will recruit pregnant women in early pregnancy（before 13 gestational&#xD;
      weeks）and following the pregnancies till delivery. The stool samples and saliva samples of&#xD;
      the recruits will be collected in 9~14,24~28 and 32~37 gestational weeks separately. The&#xD;
      investigators will also perform oral examination between 24~28 weeks and sample subgingival&#xD;
      plaque for test. Overall, all samples will be examined use 16S rRNA gene sequencing to&#xD;
      analyze microbiome. And part of the samples of GDM patients will be analyzed using&#xD;
      metagenomics. Combine with the pregnancy outcomes, the differences of gut and oral microbiome&#xD;
      between GDM patients and healthy women will be expected, as well as the natural change during&#xD;
      pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 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>the gut and oral microbiome of GDM patients during pregnancy</measure>
    <time_frame>the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)</time_frame>
    <description>The composition and species of gut and oral microbiome of GDM patients,separately in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the gut and oral microbiome of healthy pregnant women</measure>
    <time_frame>the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)</time_frame>
    <description>The composition and species of gut and oral microbiome of healthy pregnant women ,separately in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The glucose level during pregnancy</measure>
    <time_frame>the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)</time_frame>
    <description>The fasting blood glucose level and the glycosylated albumin level in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks). And the result of 75gOGTT test.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">163</enrollment>
  <condition>Gestational Diabetes</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>GDM group</arm_group_label>
    <description>pregnant women who are diagnosed after 75g OGTT test between 24~27+6 gestational weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>health group</arm_group_label>
    <description>pregnant women who pass the 75g OGTT test and aren't diagnosed as GDM, and also don't have any other conditions, like hypertensive disorders, IBD, gastrointestinal ulcer, and so on.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      stool samples were collected from objects in 3 time points：the first trimester(9-14&#xD;
      gestational weeks), the second trimester(24-28 gestational weeks) and the third&#xD;
      trimester(32-37 gestational weeks). All the samples were collected at home by the&#xD;
      participants using a PSP Spin Stool DNA kit, and the genomic DNA was extracted. The&#xD;
      researchers only amplified the hypervariable V4 region of the bacterial 16S rRNA genes.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant women who can ensure a regular prenatal check in the PUMCH OB clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  gestational age: before 13+6 weeks&#xD;
&#xD;
          -  regular prenatal care in PUMCH&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have medical history or current conditions： Gastrointestinal disorders, for example:&#xD;
             Gastritis, gastric ulcer, inflammatory bowel disease; Hypertension; Diabetes; SLE or&#xD;
             other severe CTD;&#xD;
&#xD;
          -  pregnant, combine with malignancy diseases;&#xD;
&#xD;
          -  pregnant, can't ensure regular prenatal check.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Edwards SM, Cunningham SA, Dunlop AL, Corwin EJ. The Maternal Gut Microbiome During Pregnancy. MCN Am J Matern Child Nurs. 2017 Nov/Dec;42(6):310-317. doi: 10.1097/NMC.0000000000000372.</citation>
    <PMID>28787280</PMID>
  </results_reference>
  <results_reference>
    <citation>Walker RW, Clemente JC, Peter I, Loos RJF. The prenatal gut microbiome: are we colonized with bacteria in utero? Pediatr Obes. 2017 Aug;12 Suppl 1(Suppl 1):3-17. doi: 10.1111/ijpo.12217. Epub 2017 Apr 26.</citation>
    <PMID>28447406</PMID>
  </results_reference>
  <results_reference>
    <citation>Jordan S, Baker B, Dunn A, Edwards S, Ferranti E, Mutic AD, Yang I, Rodriguez J. Maternal-Child Microbiome: Specimen Collection, Storage, and Implications for Research and Practice. Nurs Res. 2017 Mar/Apr;66(2):175-183. doi: 10.1097/NNR.0000000000000201.</citation>
    <PMID>28252577</PMID>
  </results_reference>
  <results_reference>
    <citation>Sharon G, Sampson TR, Geschwind DH, Mazmanian SK. The Central Nervous System and the Gut Microbiome. Cell. 2016 Nov 3;167(4):915-932. doi: 10.1016/j.cell.2016.10.027.</citation>
    <PMID>27814521</PMID>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 10, 2018</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal Microbiome</keyword>
  <keyword>pregnancy</keyword>
  <keyword>gestational diabetes mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</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/NCT04420507
org study id: Gut and oral microbiome of GDM
nct id: NCT04420507
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aimed to clarify the characteristics of the intestinal and oral microbiome of
      Gestational Diabetes Mellitus(GDM) patients during the whole pregnancy, try to clarify the
      relationship between the microbiome and GDM.
The aims of the study are to reveal the possibly natural change of the gut and oral
      microbiome of GDM patients during pregnancy, and to explorer whether GDM happened during
      pregnancy are associated with the maternal gut and oral microbiomes. As a perspective cohort
      study, the researchers will recruit pregnant women in early pregnancy（before 13 gestational
      weeks）and following the pregnancies till delivery. The stool samples and saliva samples of
      the recruits will be collected in 9~14,24~28 and 32~37 gestational weeks separately. The
      investigators will also perform oral examination between 24~28 weeks and sample subgingival
      plaque for test. Overall, all samples will be examined use 16S rRNA gene sequencing to
      analyze microbiome. And part of the samples of GDM patients will be analyzed using
      metagenomics. Combine with the pregnancy outcomes, the differences of gut and oral microbiome
      between GDM patients and healthy women will be expected, as well as the natural change during
      pregnancy.
observational model: Cohort
time perspective: Prospective
measure: the gut and oral microbiome of GDM patients during pregnancy
time frame: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
description: The composition and species of gut and oral microbiome of GDM patients,separately in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).
measure: the gut and oral microbiome of healthy pregnant women
time frame: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
description: The composition and species of gut and oral microbiome of healthy pregnant women ,separately in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).
measure: The glucose level during pregnancy
time frame: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
description: The fasting blood glucose level and the glycosylated albumin level in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks). And the result of 75gOGTT test.
arm group label: GDM group
description: pregnant women who are diagnosed after 75g OGTT test between 24~27+6 gestational weeks
arm group label: health group
description: pregnant women who pass the 75g OGTT test and aren't diagnosed as GDM, and also don't have any other conditions, like hypertensive disorders, IBD, gastrointestinal ulcer, and so on.
stool samples were collected from objects in 3 time points：the first trimester(9-14
      gestational weeks), the second trimester(24-28 gestational weeks) and the third
      trimester(32-37 gestational weeks). All the samples were collected at home by the
      participants using a PSP Spin Stool DNA kit, and the genomic DNA was extracted. The
      researchers only amplified the hypervariable V4 region of the bacterial 16S rRNA genes.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
citation: Edwards SM, Cunningham SA, Dunlop AL, Corwin EJ. The Maternal Gut Microbiome During Pregnancy. MCN Am J Matern Child Nurs. 2017 Nov/Dec;42(6):310-317. doi: 10.1097/NMC.0000000000000372.
PMID: 28787280
citation: Walker RW, Clemente JC, Peter I, Loos RJF. The prenatal gut microbiome: are we colonized with bacteria in utero? Pediatr Obes. 2017 Aug;12 Suppl 1(Suppl 1):3-17. doi: 10.1111/ijpo.12217. Epub 2017 Apr 26.
PMID: 28447406
citation: Jordan S, Baker B, Dunn A, Edwards S, Ferranti E, Mutic AD, Yang I, Rodriguez J. Maternal-Child Microbiome: Specimen Collection, Storage, and Implications for Research and Practice. Nurs Res. 2017 Mar/Apr;66(2):175-183. doi: 10.1097/NNR.0000000000000201.
PMID: 28252577
citation: Sharon G, Sampson TR, Geschwind DH, Mazmanian SK. The Central Nervous System and the Gut Microbiome. Cell. 2016 Nov 3;167(4):915-932. doi: 10.1016/j.cell.2016.10.027.
PMID: 27814521
responsible party type: Sponsor
mesh term: Diabetes, Gestational
sharing ipd: No