<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/NCT03263871</url>
  </required_header>
  <id_info>
    <org_study_id>19993</org_study_id>
    <nct_id>NCT03263871</nct_id>
  </id_info>
  <brief_title>PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)</brief_title>
  <official_title>Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</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 purpose of this study is to assess the effectiveness of PTM202 in treating environmental&#xD;
      enteric dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 14, 2017</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 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>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EED biomarker composite score</measure>
    <time_frame>4 months</time_frame>
    <description>composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight gain</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height gain</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of diarrheal episodes</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose hydrogen breath test</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Environmental Enteric Dysfunction</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PTM202 and micro-nutrient sprinkles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>micro-nutrient sprinkles</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>PTM202</intervention_name>
    <description>PTM202 given twice daily for 30 days.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>micro-nutrient sprinkles</intervention_name>
    <description>Micro-nutrient sprinkles will be given twice daily for 30 days.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 6 - 9 months old&#xD;
&#xD;
          -  -1&gt; Weight-for-age Z score &gt; -3&#xD;
&#xD;
          -  Parental consent to participate and receive daily supplementation with either PTM202&#xD;
             and/or micro-nutrient sprinkles, participate in specimen collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of known kidney, liver, heart, developmental, or neurologic disease&#xD;
&#xD;
          -  Allergy to milk and/or egg (assessed by history)&#xD;
&#xD;
          -  Milk intolerance (assessed by history)&#xD;
&#xD;
          -  Abnormal liver or kidney function tests&#xD;
&#xD;
          -  Family is planning to move from the study area or children is enrolled to the other&#xD;
             clinical trial within 3 months of follow up&#xD;
&#xD;
          -  Child being exclusively breast fed at the time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>9 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>International Centre for Diarrhoeal Disease Research, Bangladesh</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>April 19, 2019</last_update_submitted>
  <last_update_submitted_qc>April 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nutrition</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micronutrients</mesh_term>
    <mesh_term>Trace Elements</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03263871
org study id: 19993
nct id: NCT03263871
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental
      enteric dysfunction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: EED biomarker composite score
time frame: 4 months
description: composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein
measure: Weight gain
time frame: 4 months
measure: Height gain
time frame: 4 months
measure: Number of diarrheal episodes
time frame: 4 months
measure: Glucose hydrogen breath test
time frame: 4 months
arm group label: Intervention
arm group type: Experimental
description: PTM202 and micro-nutrient sprinkles
arm group label: Control
arm group type: Other
description: micro-nutrient sprinkles
intervention type: Dietary Supplement
intervention name: PTM202
description: PTM202 given twice daily for 30 days.
arm group label: Intervention
intervention type: Dietary Supplement
intervention name: micro-nutrient sprinkles
description: Micro-nutrient sprinkles will be given twice daily for 30 days.
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 6 Months
maximum age: 9 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Bangladesh
responsible party type: Sponsor
mesh term: Micronutrients
mesh term: Trace Elements
sharing ipd: No