<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/NCT03785093</url>
  </required_header>
  <id_info>
    <org_study_id>Smart-002</org_study_id>
    <nct_id>NCT03785093</nct_id>
  </id_info>
  <brief_title>Intestinal Microbiota on Allergy, Growth and Development</brief_title>
  <acronym>SMARTGenHK</acronym>
  <official_title>Intestinal Microbiota on Allergy, Growth and Development of the Next Generation in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      There is growing evidence that microbial programming beginning in-utero can be a central&#xD;
      component for a balanced development of innate immunity and optimal growth and development in&#xD;
      newborns. However, the specific types of bacteria along with their cross-talk with maternal&#xD;
      and fetal host factors are far from being clear. The investigators hypothesize microbial&#xD;
      compositions at different body sites of pregnant women are associated with early-life&#xD;
      microbiota of their offspring as well as growth, neurodevelopment and the development of&#xD;
      allergic and neurocognitive disorders. This is a prospective birth cohort study involving&#xD;
      Chinese mother-child pairs. The investigators will follow up 120 pregnant women from first&#xD;
      trimester until childbirth, and the child until three years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our unit is one of the centres contributing to the International multicentre HAPO study. We&#xD;
      recruited 1760 Chinese pregnant women between 2000 and 2005. The HAPO study investigated&#xD;
      whether any adverse outcome was associated with mild degree of GDM. All mothers underwent a&#xD;
      75-gram OGTT at 24-32 weeks gestation, but clinicians were blinded to the results as long as&#xD;
      the fasting PG was ≤ 5.8 mmol/L &amp; 2-hour PG ≤ 11.1 mmol/L. The maternal serum C-peptide and&#xD;
      HbA1c, cord serum C-peptide and early neonatal PG, pregnancy outcome and the neonatal&#xD;
      anthropometric parameters are available for future study. This is so far the largest cohort&#xD;
      in a Chinese population who has been investigated for glycaemia during pregnancy, but with&#xD;
      OGTT results remained undisclosed to subjects and clinicians. This unique cohort can allow us&#xD;
      to study the effect of in-utero hyperglycemia on the cardiometabolic risks at childhood,&#xD;
      adolescence and adulthood.&#xD;
&#xD;
      Eligible subjects are all mother-child pairs participating in the original HAPO study.&#xD;
      Children born preterm before 37 weeks of gestation, non-Chinese and whose mother's OGTT&#xD;
      result were unblinded during pregnancy will be excluded.The family (the child and the mother)&#xD;
      will be invited for a third follow-up assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite allergy disease</measure>
    <time_frame>3 years of age</time_frame>
    <description>wheezing, asthma, skin atopy, food allergy</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Chinese Family</arm_group_label>
    <description>Chinese parents and their offsprings</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      i) Blood, urine and stool samples ii) Skin, nasal and buccal swabs iii) Maternal vaginal&#xD;
      swabs and placental tissue biopsy iv) Breast milk&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese families in Hong Kong&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Expectant ethnic Chinese mothers aged 18 - 45 years who are in the first trimester of&#xD;
             pregnancy&#xD;
&#xD;
          2. Singleton pregnancy&#xD;
&#xD;
          3. Plan to give birth in the Prince of Wales Hospital, Hong Kong and stay with the child&#xD;
             in Hong Kong for the next 3 years&#xD;
&#xD;
          4. Willing to provide serial biological samples for microbiota detection&#xD;
&#xD;
          5. Willing for her coming newborn to be prospectively followed up for clinical and&#xD;
             microbiota data collection in PWH&#xD;
&#xD;
          6. Participate voluntarily and capable of giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant medical conditions especially those required long term medications, such&#xD;
             as oral steroid, antihypertensive drugs, diabetic medications and lipid-lowering&#xD;
             agents, during or before pregnancy&#xD;
&#xD;
          2. History of chronic inflammatory or neoplastic diseases involving the gastrointestinal&#xD;
             tract (e.g. inflammatory bowel disease, coeliac disease, colorectal cancer)&#xD;
&#xD;
          3. Significant pregnancy complications, such as intrauterine foetal demise/stillbirth,&#xD;
             extreme prematurity, or pre-labour rupture of membranes before 24 weeks&#xD;
&#xD;
          4. Mother with mental incapacity such that they are not able to give informed consent&#xD;
&#xD;
          5. Foetal chromosomal or clinically significant structural abnormalities&#xD;
&#xD;
          6. The current pregnancy is a conception through either sperm or ovum donation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women who are in the first trimester of pregnancy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ting Fan Leung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong, China</state>
        <zip>Shatin</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Ting-fan Leung</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Microbiota, Allergy, Growth, Development, offspring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03785093
org study id: Smart-002
nct id: NCT03785093
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is growing evidence that microbial programming beginning in-utero can be a central
      component for a balanced development of innate immunity and optimal growth and development in
      newborns. However, the specific types of bacteria along with their cross-talk with maternal
      and fetal host factors are far from being clear. The investigators hypothesize microbial
      compositions at different body sites of pregnant women are associated with early-life
      microbiota of their offspring as well as growth, neurodevelopment and the development of
      allergic and neurocognitive disorders. This is a prospective birth cohort study involving
      Chinese mother-child pairs. The investigators will follow up 120 pregnant women from first
      trimester until childbirth, and the child until three years of age.
Our unit is one of the centres contributing to the International multicentre HAPO study. We
      recruited 1760 Chinese pregnant women between 2000 and 2005. The HAPO study investigated
      whether any adverse outcome was associated with mild degree of GDM. All mothers underwent a
      75-gram OGTT at 24-32 weeks gestation, but clinicians were blinded to the results as long as
      the fasting PG was ≤ 5.8 mmol/L & 2-hour PG ≤ 11.1 mmol/L. The maternal serum C-peptide and
      HbA1c, cord serum C-peptide and early neonatal PG, pregnancy outcome and the neonatal
      anthropometric parameters are available for future study. This is so far the largest cohort
      in a Chinese population who has been investigated for glycaemia during pregnancy, but with
      OGTT results remained undisclosed to subjects and clinicians. This unique cohort can allow us
      to study the effect of in-utero hyperglycemia on the cardiometabolic risks at childhood,
      adolescence and adulthood.

      Eligible subjects are all mother-child pairs participating in the original HAPO study.
      Children born preterm before 37 weeks of gestation, non-Chinese and whose mother's OGTT
      result were unblinded during pregnancy will be excluded.The family (the child and the mother)
      will be invited for a third follow-up assessment.
observational model: Family-Based
time perspective: Prospective
measure: Composite allergy disease
time frame: 3 years of age
description: wheezing, asthma, skin atopy, food allergy
arm group label: Chinese Family
description: Chinese parents and their offsprings
i) Blood, urine and stool samples ii) Skin, nasal and buccal swabs iii) Maternal vaginal
      swabs and placental tissue biopsy iv) Breast milk
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Women who are in the first trimester of pregnancy
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ting Fan Leung
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Ting-fan Leung
investigator title: Professor
mesh term: Hypersensitivity
sharing ipd: Undecided