<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/NCT01721512</url>
  </required_header>
  <id_info>
    <org_study_id>Project Grow</org_study_id>
    <nct_id>NCT01721512</nct_id>
  </id_info>
  <brief_title>The Growth and Development of Breast and Formula Fed Term Asian Infants</brief_title>
  <official_title>The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fonterra Brands (Singapore) PTE LTD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Indonesia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta,&#xD;
      Indonesia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</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>Infant weight, body length head circumference</measure>
    <time_frame>12 months</time_frame>
    <description>Infant weight, body length head circumference at enrolment, 2 weeks, 4 weeks and monthly thereafter until 6 months, and then at 8, 10 and 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal tolerance</measure>
    <time_frame>6 months</time_frame>
    <description>Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicators or formula tolerance</measure>
    <time_frame>12 months</time_frame>
    <description>Indicators or formula tolerance: crying, irritability, sleep patterns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General health</measure>
    <time_frame>12 months</time_frame>
    <description>General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut integrity</measure>
    <time_frame>3 months</time_frame>
    <description>Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microflora</measure>
    <time_frame>3 months</time_frame>
    <description>Gut microflora: real time PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Developmental progress</measure>
    <time_frame>12 months</time_frame>
    <description>Developmental progress: assessed by Ages and Stages</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>Growth</condition>
  <arm_group>
    <arm_group_label>Breast-fed infants</arm_group_label>
    <description>80 infants of mothers who plan to exclusively breastfeed for at least 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formula-fed infants</arm_group_label>
    <description>Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding.&#xD;
Mother consents to her infant receiving trial infant formula for 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breastfeeding</intervention_name>
    <arm_group_label>Breast-fed infants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infant formula</intervention_name>
    <arm_group_label>Formula-fed infants</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Faecal samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy infants recruited from Jati Padang, Pasar Minggu District, South Jakarta, Indonesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4&#xD;
             months; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight&#xD;
             greater than or equal to 2.5 kg and equal or less than 4.75 kg.&#xD;
&#xD;
          -  Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal&#xD;
             to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant&#xD;
             with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg&#xD;
             and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial&#xD;
             infant formula for 12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Severe congenital or metabolic disease likely to affect infant feeding or infant&#xD;
             growth.&#xD;
&#xD;
          -  2. Multiple birth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Weeks</minimum_age>
    <maximum_age>6 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Agus Firmansyah, Professor, MD, PhD, SpA(K)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indonesia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitas Indonesia</name>
      <address>
        <city>Jakarta</city>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Prof. Agus Firmansyah, MD, Ph.D</investigator_full_name>
    <investigator_title>Professor and Chief, Division of Gastrohepatology, Department of Child Health, Medical Faculty, University of Indonesia</investigator_title>
  </responsible_party>
  <keyword>Prospective observational study</keyword>
  <keyword>Breast feeding</keyword>
  <keyword>Infant formula</keyword>
  <keyword>Infant</keyword>
  <keyword>Indonesia</keyword>
  <!-- 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/NCT01721512
org study id: Project Grow
nct id: NCT01721512
lead sponsor: 
collaborator: 
has dmc: Yes
Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta,
      Indonesia
observational model: Cohort
time perspective: Prospective
measure: Infant weight, body length head circumference
time frame: 12 months
description: Infant weight, body length head circumference at enrolment, 2 weeks, 4 weeks and monthly thereafter until 6 months, and then at 8, 10 and 12 months.
measure: Gastrointestinal tolerance
time frame: 6 months
description: Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months
measure: Indicators or formula tolerance
time frame: 12 months
description: Indicators or formula tolerance: crying, irritability, sleep patterns
measure: General health
time frame: 12 months
description: General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage
measure: Gut integrity
time frame: 3 months
description: Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin
measure: Gut microflora
time frame: 3 months
description: Gut microflora: real time PCR
measure: Developmental progress
time frame: 12 months
description: Developmental progress: assessed by Ages and Stages
arm group label: Breast-fed infants
description: 80 infants of mothers who plan to exclusively breastfeed for at least 6 months.
arm group label: Formula-fed infants
description: Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding.
Mother consents to her infant receiving trial infant formula for 12 months
intervention type: Other
intervention name: Breastfeeding
arm group label: Breast-fed infants
intervention type: Other
intervention name: Infant formula
arm group label: Formula-fed infants
Faecal samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Weeks
maximum age: 6 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Agus Firmansyah, Professor, MD, PhD, SpA(K)
role: Principal Investigator
affiliation: Indonesia University
facility: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Prof. Agus Firmansyah, MD, Ph.D
investigator title: Professor and Chief, Division of Gastrohepatology, Department of Child Health, Medical Faculty, University of Indonesia