<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/NCT03770143</url>
  </required_header>
  <id_info>
    <org_study_id>ANCL034</org_study_id>
    <nct_id>NCT03770143</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance</brief_title>
  <official_title>Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</source>
  <brief_summary>
    <textblock>
      Depending on recent studies in literature the investigators aimed to compare whether&#xD;
      gastrointestinal tolerance differs between infants fed with palm olein containing or palm&#xD;
      olein free formulas. Besides it is showed that palm olein containing formulas decreases the&#xD;
      absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that&#xD;
      intestinal flora might be affected as a reason of these specialties. This study also aimed to&#xD;
      investigate with culture-independent methods whether feeding infants with palm olein free&#xD;
      formula results in the modification of their intestinal microbiota in such a way that is&#xD;
      similar to breastfed ones.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent studies in literature the investigators aimed to compare whether gastrointestinal&#xD;
      tolerance differs between infants fed with palm olein containing or palm olein free formulas.&#xD;
      Besides it is showed that palm olein containing formulas decreases the absorption of fat and&#xD;
      calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be&#xD;
      affected as a reason of these specialties. This study also aimed to investigate with&#xD;
      culture-independent methods whether feeding infants with palm olein free formula results in&#xD;
      the modification of their intestinal microbiota in such a way that is similar to breastfed&#xD;
      ones.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Stool consistency</measure>
    <time_frame>10 weeks</time_frame>
    <description>Amsterdam Infant Stool Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bacteria Count</measure>
    <time_frame>10 weeks</time_frame>
    <description>number of the copy of DNA of Intestinal Flora Content</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Feeding; Disorder, Nonorganic Origin</condition>
  <condition>Calcium Disorder</condition>
  <condition>Intestinal Bacteria Flora Disturbance</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Infants feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Infants feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Feeding with palm olein formula</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 90 healthy infants (30 under breast-feeding, 30 feeding with palm olein free&#xD;
        formula and 30 feeding with palm olein formula) will be included. Infants feeding enterally&#xD;
        more than %70 with breast milk will be considered as breast-feeding. Infants who had not&#xD;
        adequate weight gain and need formula will be randomized to receive either palm olein or&#xD;
        palm olein free term formula in addition to mother milk. Parental informed consent will be&#xD;
        taken and infants whose parents give permission will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The data of the patients who fulfilled the following criteria are evaluated.&#xD;
&#xD;
          1. Term infants between 38 and 40 weeks of gestational age and/or with a birth weight of&#xD;
             &gt; 2500grams who are either breastfed or formula fed.&#xD;
&#xD;
             Selection of the subgroup using oral nutrition&#xD;
&#xD;
          2. Feeding predominantly with palm olein free formula if presence in addition to breast&#xD;
             milk for 8 weeks of life&#xD;
&#xD;
          3. Feeding with other formulas including palm olein if presence in addition to breast&#xD;
             milk for 8 weeks of life Selection of the subgroup not using oral nutritional&#xD;
             supplement (control group)&#xD;
&#xD;
          4. Having similar demographical properties with infants feeding with breast milk (gender,&#xD;
             age, weight, height)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with major congenital abnormalities will be excluded.&#xD;
&#xD;
          -  Infants with lack of data will also be excluded.&#xD;
&#xD;
          -  Infants, whose parents don't agree with informed consent, will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seda Yilmaz Semerci</last_name>
    <role>Study Director</role>
    <affiliation>Kanuni SSTRH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kanuni Sultan Suleyman Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Kucukcekmece</state>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>May 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>April 22, 2019</last_update_submitted>
  <last_update_submitted_qc>April 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Merih Cetinkaya</investigator_full_name>
    <investigator_title>Associate Professor, MD,PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysbiosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03770143
org study id: ANCL034
nct id: NCT03770143
lead sponsor: 
Depending on recent studies in literature the investigators aimed to compare whether
      gastrointestinal tolerance differs between infants fed with palm olein containing or palm
      olein free formulas. Besides it is showed that palm olein containing formulas decreases the
      absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that
      intestinal flora might be affected as a reason of these specialties. This study also aimed to
      investigate with culture-independent methods whether feeding infants with palm olein free
      formula results in the modification of their intestinal microbiota in such a way that is
      similar to breastfed ones.
Recent studies in literature the investigators aimed to compare whether gastrointestinal
      tolerance differs between infants fed with palm olein containing or palm olein free formulas.
      Besides it is showed that palm olein containing formulas decreases the absorption of fat and
      calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be
      affected as a reason of these specialties. This study also aimed to investigate with
      culture-independent methods whether feeding infants with palm olein free formula results in
      the modification of their intestinal microbiota in such a way that is similar to breastfed
      ones.
observational model: Case-Control
time perspective: Prospective
measure: Stool consistency
time frame: 10 weeks
description: Amsterdam Infant Stool Scale
measure: Bacteria Count
time frame: 10 weeks
description: number of the copy of DNA of Intestinal Flora Content
arm group label: Group 1
description: Infants feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life
arm group label: Group 2
description: Infants feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life
arm group label: Group 3
description: Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)
intervention type: Other
intervention name: Feeding with palm olein formula
arm group label: Group 1
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Seda Yilmaz Semerci
role: Study Director
affiliation: Kanuni SSTRH
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Merih Cetinkaya
investigator title: Associate Professor, MD,PhD
mesh term: Dysbiosis