<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/NCT04450056</url>
  </required_header>
  <id_info>
    <org_study_id>2020-3676-10314b</org_study_id>
    <nct_id>NCT04450056</nct_id>
  </id_info>
  <brief_title>Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants</brief_title>
  <official_title>Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aga Khan University</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>
      In Pakistan, breastfeeding is widely practiced. National data suggests that 94% of infants &lt;2&#xD;
      years of age receive breastmilk at some point. However, the introduction of complementary&#xD;
      foods often occurs early. At 3 months of age, it is suggested that only 54% of Pakistani&#xD;
      infants are exclusively breastfed. This declines with each month of age. Because the&#xD;
      production and release of breastmilk is influenced by the frequency and intensity of&#xD;
      suckling, early initiation of complementary feeding can reduce breastmilk output. Given that&#xD;
      complementary foods are introduced early within Pakistan, we hypothesize that breastmilk&#xD;
      composition will change between 1 and 3 months postpartum among those mother-infant pairs if&#xD;
      nutritive complementary foods are introduced early (i.e., before 6 months). In this study, we&#xD;
      aim to better understand how breastmilk composition changes over time among infants recruited&#xD;
      at 1 month of age who are exclusively breastfed or receive only non-nutritive feeds. This is&#xD;
      a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial&#xD;
      (ClinicalTrials.gov Identifier: NCT03287882).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Change in breastmilk macronutrient composition</measure>
    <time_frame>1 and 3 months postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in breastmilk micronutrient composition</measure>
    <time_frame>1 and 3 months postpartum</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in breastmilk bioactive composition</measure>
    <time_frame>1 and 3 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breastmilk microbiome</measure>
    <time_frame>1 and 3 months postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in infant microbiome</measure>
    <time_frame>1 and 3 months postpartum</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Breast Milk Collection</condition>
  <condition>Infant Development</condition>
  <arm_group>
    <arm_group_label>Mother-infant pairs</arm_group_label>
    <description>Mothers with a term-born (&gt;37 weeks gestation) infant whom they are exclusively or predominantly breastfeeding at 1 month postpartum. Mothers must be enrolled in the MaPPS Trial (ClinicalTrials.gov Identifier: NCT03287882).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Mother-infant pairs</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Breastmilk sample Rectal swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Mothers and infants enrolled in the MaPPS Trial in Matiari District, Pakistan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in the MaPPS Trial&#xD;
&#xD;
          -  Mothers must report practicing exclusive or predominant breastfeeding (i.e.,&#xD;
             breastmilk only or breastmilk and non-nutritive feeds only)&#xD;
&#xD;
          -  The infant must be term-born (&gt;37 weeks gestation)&#xD;
&#xD;
          -  Infant must be 1 month + 14 days old at the time of recruitment&#xD;
&#xD;
          -  Mothers must be willing to provide a complete breastmilk expression from one breast&#xD;
             (either via breast pump or hand expression)&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mother reports mixed feeding of her infant with nutritive feeds (i.e., any provision&#xD;
             of formula or animal milk)&#xD;
&#xD;
          -  The infant was born preterm (earlier than 37 weeks gestation)&#xD;
&#xD;
          -  Mother does not wish to provide a complete breast expression of one breast&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Matiari Research and Training Centre</name>
      <address>
        <city>Matiari</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>November 17, 2020</last_update_submitted>
  <last_update_submitted_qc>November 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Dr Zulfiqar Ahmed Bhutta</investigator_full_name>
    <investigator_title>Founding Chair, Centre of Excellence in Women and Child Health</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Please contact the Primary Investigator directly for more details.</ipd_description>
  </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/NCT04450056
org study id: 2020-3676-10314b
nct id: NCT04450056
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Pakistan, breastfeeding is widely practiced. National data suggests that 94% of infants <2
      years of age receive breastmilk at some point. However, the introduction of complementary
      foods often occurs early. At 3 months of age, it is suggested that only 54% of Pakistani
      infants are exclusively breastfed. This declines with each month of age. Because the
      production and release of breastmilk is influenced by the frequency and intensity of
      suckling, early initiation of complementary feeding can reduce breastmilk output. Given that
      complementary foods are introduced early within Pakistan, we hypothesize that breastmilk
      composition will change between 1 and 3 months postpartum among those mother-infant pairs if
      nutritive complementary foods are introduced early (i.e., before 6 months). In this study, we
      aim to better understand how breastmilk composition changes over time among infants recruited
      at 1 month of age who are exclusively breastfed or receive only non-nutritive feeds. This is
      a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial
      (ClinicalTrials.gov Identifier: NCT03287882).
observational model: Cohort
time perspective: Prospective
measure: Change in breastmilk macronutrient composition
time frame: 1 and 3 months postpartum
measure: Change in breastmilk micronutrient composition
time frame: 1 and 3 months postpartum
measure: Change in breastmilk bioactive composition
time frame: 1 and 3 months postpartum
measure: Change in breastmilk microbiome
time frame: 1 and 3 months postpartum
measure: Change in infant microbiome
time frame: 1 and 3 months postpartum
arm group label: Mother-infant pairs
description: Mothers with a term-born (>37 weeks gestation) infant whom they are exclusively or predominantly breastfeeding at 1 month postpartum. Mothers must be enrolled in the MaPPS Trial (ClinicalTrials.gov Identifier: NCT03287882).
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: Mother-infant pairs
Breastmilk sample Rectal swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 15 Years
maximum age: 25 Years
healthy volunteers: No
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Dr Zulfiqar Ahmed Bhutta
investigator title: Founding Chair, Centre of Excellence in Women and Child Health
sharing ipd: Yes
ipd description: Please contact the Primary Investigator directly for more details.