xml: <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/NCT05979532</url>
    </required_header>
    <id_info>
      <org_study_id>SBB21R&amp;35943</org_study_id>
      <nct_id>NCT05979532</nct_id>
    </id_info>
    <brief_title>A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk</brief_title>
    <acronym>White Gold</acronym>
    <official_title>A Longitudinal Prospective, Observational, Cohort Study in Lactating Mothers and Their Newborns to Further Unravel the Complexity of Human Milk</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nutricia Research</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nutricia Research</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 current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers&#xD;
        and their newborns will make it possible to explore human milk composition across different&#xD;
        lactation stages, between different human milk groups, and in relation to maternal,&#xD;
        perinatal, infant, and sample characteristics as well as to the microbiota of the infant.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2027</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>Examples of exploratory outcome parameters in this study are the following human milk outcome parameters.</measure>
      <time_frame>at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.</time_frame>
      <description>Laboratory analyses of Human Milk Oligosaccharides (HMOs), proteins, amino acids, lipids, and fatty acids.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The following exploratory faecal outcome parameter will be analysed if sufficient faecal samples are collected.</measure>
      <time_frame>at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.</time_frame>
      <description>Laboratory analyses of Infant's faecal microbiome composition.</description>
    </primary_outcome>
    <enrollment type="Anticipated">172</enrollment>
    <condition>Breast Feeding</condition>
    <condition>Milk, Human</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        The samples may be used in future genetic research. Future genetic research on the samples&#xD;
        will only be done when the subject has given a separate consent for this.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          120 Lactating mothers who have the intention to breastfeed for at least 6 months and their&#xD;
          newborns.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women in the third trimester of pregnancy (≥28 weeks) who have the intention&#xD;
               to provide breastfeeding for at least 6 months post-partum.&#xD;
  &#xD;
            -  Age ≥ 18 years.&#xD;
  &#xD;
            -  Willingness to provide residual human milk.&#xD;
  &#xD;
            -  Living in proximity of NCRU (clinical site in NL).&#xD;
  &#xD;
            -  Dutch speaking and reading.&#xD;
  &#xD;
            -  Freezer -18°C available.&#xD;
  &#xD;
            -  Having mobile phone, tablet, or computer available.&#xD;
  &#xD;
            -  Signed informed consent from the subject (pregnant woman).&#xD;
  &#xD;
            -  Signed informed consent from the other parent and/or legally acceptable&#xD;
               representative, of the unborn baby(s), aged ≥ 18 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women known positive for human immunodeficiency virus (HIV), hepatitis B&#xD;
               (HBV), or hepatitis C (HCV).&#xD;
  &#xD;
            -  Multiple pregnancy &gt; 2.&#xD;
  &#xD;
            -  Incapability of subjects to comply with study protocol as per the judgment of the site&#xD;
               staff (e.g. fluency in local language, access to laptop/smartphone devices and&#xD;
               internet connection required for data collection).&#xD;
  &#xD;
            -  Women (and their unborn baby(s)) with current or intended participation in any other&#xD;
               clinical study involving investigational or marketed products.&#xD;
  &#xD;
            -  Employees and/or children/family members or relatives of employees of Nutricia&#xD;
               Research or the participating site.&#xD;
  &#xD;
          Continuation exclusion criteria (after birth)&#xD;
  &#xD;
            -  Stillbirth&#xD;
  &#xD;
            -  Newborn having any congenital abnormality, chromosomal disorder or severe disease that&#xD;
               would prevent the infant from breastfeeding and/or growing normally based on the&#xD;
               opinion of a health care professional and/or study physician.&#xD;
  &#xD;
            -  No donation of any milk sample within the first 8 weeks postpartum (timepoints week 1,&#xD;
               week 1.5, and week 4).&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>The study population consists of lactating mothers and their newborn.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Danone Nutricia Research N Research</last_name>
      <phone>+31 30 2095 000</phone>
      <email>register.clinicalresearchnutricia@danone.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Danone Nutricia Research</name>
        <address>
          <city>Utrecht</city>
          <zip>3584CT</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <email>ncru.utrecht@danone.com</email>
      </contact>
      <investigator>
        <last_name>M. Visser</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>White Gold</keyword>
    <keyword>Breast Feeding</keyword>
    <keyword>Human milk</keyword>
    <keyword>Research</keyword>
    <keyword>Lactation</keyword>
    <keyword>Human Milk Oligosaccharide</keyword>
    <keyword>HMO</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979532
  org study id: SBB21R&35943
  nct id: NCT05979532
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers
        and their newborns will make it possible to explore human milk composition across different
        lactation stages, between different human milk groups, and in relation to maternal,
        perinatal, infant, and sample characteristics as well as to the microbiota of the infant.
  observational model: Cohort
  time perspective: Prospective
  measure: Examples of exploratory outcome parameters in this study are the following human milk outcome parameters.
  time frame: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
  description: Laboratory analyses of Human Milk Oligosaccharides (HMOs), proteins, amino acids, lipids, and fatty acids.
  measure: The following exploratory faecal outcome parameter will be analysed if sufficient faecal samples are collected.
  time frame: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
  description: Laboratory analyses of Infant's faecal microbiome composition.
  The samples may be used in future genetic research. Future genetic research on the samples
        will only be done when the subject has given a separate consent for this.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: The study population consists of lactating mothers and their newborn.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Danone Nutricia Research N Research
  phone: +31 30 2095 000
  email: register.clinicalresearchnutricia@danone.com
  facility: 
  contact: 
  investigator: 
  country: Netherlands
  responsible party type: Sponsor
  sharing ipd: No