<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/NCT03019250</url>
  </required_header>
  <id_info>
    <org_study_id>2016670</org_study_id>
    <nct_id>NCT03019250</nct_id>
  </id_info>
  <brief_title>A Trial of Enteral Colostrum on Clinical Outcomes in Critically Ill Patients</brief_title>
  <official_title>Effects of Colostrum Supplement on Inflammatory and Growth Factors, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Nutrition and Food Technology Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Nutrition and Food Technology Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids,&#xD;
      selenium, and antioxidants has been suggested to reduce infections and improve recovery from&#xD;
      critical illness. However, the effects of colostrum on clinical outcomes in critical ill&#xD;
      patients has not been investigated. In current trial, intensive care unit patients with&#xD;
      enteral feeding will receive either enteral colostrum or maltodextrin as placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double blind, controlled trial will be conducted in general intensive care unit&#xD;
      (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and&#xD;
      explanation of the risks and benefits of the study, written consent form will be completed.&#xD;
      Intervention patients will be received 20 g/day of colostrum along with enteral formula and&#xD;
      control patients will be received maltodextrin along with enteral formula. Patients will be&#xD;
      assessed for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and&#xD;
      6 months mortality and inflammatory and immune markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">November 7, 2018</completion_date>
  <primary_completion_date type="Actual">November 7, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of infection</measure>
    <time_frame>Day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>28-day Mortality</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month mortality</measure>
    <time_frame>month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in ICU</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Immunity Markers</measure>
    <time_frame>baseline, Day 5, Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Inflammatory Markers</measure>
    <time_frame>baseline, Day 5, Day 10</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Critical Illness</condition>
  <condition>Infection Complication</condition>
  <condition>Multiple Organ Dysfunction Syndrome</condition>
  <arm_group>
    <arm_group_label>Colostrum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Colostrum</intervention_name>
    <description>Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.</description>
    <arm_group_label>Colostrum</arm_group_label>
    <other_name>Bovine Colostrum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>Maltodextrin mixed with water given via NG tube Q 4 hours.</description>
    <arm_group_label>Maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt;18 years old) admitted to ICU&#xD;
&#xD;
          -  Start of study intervention within 48 hours after ICU admission&#xD;
&#xD;
          -  Expected to require enteral nutrition for at least 72 hours aiming for full enteral&#xD;
             nutrition and receive at least 80 percent of enteral formula during the first 48 hour&#xD;
&#xD;
          -  Written informed consent of patient or written informed consent of legal&#xD;
             representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrollment in a related ICU interventional study&#xD;
&#xD;
          -  Requiring other specific enteral nutrition for medical reason&#xD;
&#xD;
          -  Death or Discharge before 5th day&#xD;
&#xD;
          -  Having any contra-indication to receive enteral nutrition&#xD;
&#xD;
          -  Pregnant patients or lactating with the intent to breastfeed&#xD;
&#xD;
          -  BMI &lt;18 or &gt; 40.0 kg/m2&#xD;
&#xD;
          -  Have life expectancy of &lt;6 mo&#xD;
&#xD;
          -  Patients who are moribund&#xD;
&#xD;
          -  History of allergy or intolerance to the study product components&#xD;
&#xD;
          -  Receiving colostrum during two weeks before start study product&#xD;
&#xD;
          -  Have other reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ghazaleh Eslamian, MS,PhDcandid</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Nutrition and Food Technology Research Institute</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <reference>
    <citation>Kim JW, Jeon WK, Kim EJ. Combined effects of bovine colostrum and glutamine in diclofenac-induced bacterial translocation in rat. Clin Nutr. 2005 Oct;24(5):785-93. doi: 10.1016/j.clnu.2005.04.004.</citation>
    <PMID>15919136</PMID>
  </reference>
  <reference>
    <citation>Rathe M, Muller K, Sangild PT, Husby S. Clinical applications of bovine colostrum therapy: a systematic review. Nutr Rev. 2014 Apr;72(4):237-54. doi: 10.1111/nure.12089. Epub 2014 Feb 26.</citation>
    <PMID>24571383</PMID>
  </reference>
  <reference>
    <citation>Benson KF, Carter SG, Patterson KM, Patel D, Jensen GS. A novel extract from bovine colostrum whey supports anti-bacterial and anti-viral innate immune functions in vitro and in vivo: I. Enhanced immune activity in vitro translates to improved microbial clearance in animal infection models. Prev Med. 2012 May;54 Suppl:S116-23. doi: 10.1016/j.ypmed.2011.12.023. Epub 2011 Dec 28.</citation>
    <PMID>22227281</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>November 9, 2018</last_update_submitted>
  <last_update_submitted_qc>November 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Nutrition and Food Technology Institute</investigator_affiliation>
    <investigator_full_name>Ghazaleh Eslamian</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Colostrum</keyword>
  <keyword>Critical Care Outcomes</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Infection</keyword>
  <keyword>mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Multiple Organ Failure</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/NCT03019250
org study id: 2016670
nct id: NCT03019250
lead sponsor: 
has dmc: Yes
Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids,
      selenium, and antioxidants has been suggested to reduce infections and improve recovery from
      critical illness. However, the effects of colostrum on clinical outcomes in critical ill
      patients has not been investigated. In current trial, intensive care unit patients with
      enteral feeding will receive either enteral colostrum or maltodextrin as placebo.
A randomized, double blind, controlled trial will be conducted in general intensive care unit
      (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and
      explanation of the risks and benefits of the study, written consent form will be completed.
      Intervention patients will be received 20 g/day of colostrum along with enteral formula and
      control patients will be received maltodextrin along with enteral formula. Patients will be
      assessed for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and
      6 months mortality and inflammatory and immune markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Occurrence of infection
time frame: Day 28
measure: 28-day Mortality
time frame: Day 28
measure: 6-month mortality
time frame: month 6
measure: Length of stay in ICU
time frame: Day 28
measure: Serum Immunity Markers
time frame: baseline, Day 5, Day 10
measure: Serum Inflammatory Markers
time frame: baseline, Day 5, Day 10
arm group label: Colostrum
arm group type: Experimental
description: Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs.
arm group label: Maltodextrin
arm group type: Placebo Comparator
description: Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
intervention type: Dietary Supplement
intervention name: Colostrum
description: Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
arm group label: Colostrum
other name: Bovine Colostrum
intervention type: Dietary Supplement
intervention name: Maltodextrin
description: Maltodextrin mixed with water given via NG tube Q 4 hours.
arm group label: Maltodextrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ghazaleh Eslamian, MS,PhDcandid
role: Principal Investigator
affiliation: National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran
facility: 
country: Iran, Islamic Republic of
citation: Kim JW, Jeon WK, Kim EJ. Combined effects of bovine colostrum and glutamine in diclofenac-induced bacterial translocation in rat. Clin Nutr. 2005 Oct;24(5):785-93. doi: 10.1016/j.clnu.2005.04.004.
PMID: 15919136
citation: Rathe M, Muller K, Sangild PT, Husby S. Clinical applications of bovine colostrum therapy: a systematic review. Nutr Rev. 2014 Apr;72(4):237-54. doi: 10.1111/nure.12089. Epub 2014 Feb 26.
PMID: 24571383
citation: Benson KF, Carter SG, Patterson KM, Patel D, Jensen GS. A novel extract from bovine colostrum whey supports anti-bacterial and anti-viral innate immune functions in vitro and in vivo: I. Enhanced immune activity in vitro translates to improved microbial clearance in animal infection models. Prev Med. 2012 May;54 Suppl:S116-23. doi: 10.1016/j.ypmed.2011.12.023. Epub 2011 Dec 28.
PMID: 22227281
responsible party type: Principal Investigator
investigator affiliation: National Nutrition and Food Technology Institute
investigator full name: Ghazaleh Eslamian
investigator title: Principal Investigator
mesh term: Critical Illness
mesh term: Multiple Organ Failure
sharing ipd: Undecided