<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/NCT04488718</url>
  </required_header>
  <id_info>
    <org_study_id>ESj-01</org_study_id>
    <nct_id>NCT04488718</nct_id>
  </id_info>
  <brief_title>ESj- Powder Complete T&amp;A Study</brief_title>
  <acronym>ESj</acronym>
  <official_title>Evaluation of Tolerance and Acceptability of EnergieShake® Junior Powder Complete</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anaiah Healthcare Pvt Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brighton and Sussex University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Great Ormond Street Hospital for Children NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Anaiah Healthcare Pvt Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to gather data on the tolerance and acceptability of a new ONS&#xD;
      (ESj-powder complete) in children currently taking ONS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to demonstrate the tolerance and acceptability of the test product&#xD;
      when consumed by children who are currently prescribed (a similar) ONS. The data generated&#xD;
      from this study will be submitted to the ACBS, who will consider it for reimbursement as a&#xD;
      Food for Special Medical Purpose (FSMP) in the UK.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 24, 2020</start_date>
  <completion_date type="Anticipated">May 24, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 24, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability &amp; Tolerance: questionnaire</measure>
    <time_frame>7 days</time_frame>
    <description>Acceptability of test product will be tested in children using a questionnaire with a liking scale (Liking Scale - 1-10 - 0 being dislike and 10 being like a lot) and compliance (intake/day versus prescribed dose) of the test product over a 7 day period and compared to acceptability when consuming their current oral nutritional supplement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal Tolerance</measure>
    <time_frame>7 days</time_frame>
    <description>Gastrointestinal (GI) tolerance of test product will be determined in children using a questionnaire detailing daily bowel habits and symptoms that occur (new or worsening) while consuming the test product over a 7 day period and compared to GI tolerance when consuming their current oral nutritional supplement. This is established using a combination of the Bristol Stool Chart scoring (BSC - type 1 up to type 7) before and during the study along with number of bowel movements/day and stool consistency.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Child Nutrition Disorders</condition>
  <condition>Child Malnutrition</condition>
  <arm_group>
    <arm_group_label>EnergieShake® Junior Powder Complete (test)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EnergieShake® Junior Powder Complete will be consumed by children, as a supplement to normal diet, over a period of 7 day period to determine its acceptability (liking, compliance) and tolerance (gastro-intestinal tolerance). The dose will be the same as currently consumed product (all children recruited to the study will be consuming an oral nutritional supplement).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EnergieShake® Junior Powder Complete</intervention_name>
    <description>Oral Nutritional Supplement</description>
    <arm_group_label>EnergieShake® Junior Powder Complete (test)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;1-18 years of age&#xD;
&#xD;
          -  Children currently prescribed and consuming Oral Nutritional Supplements (ONS)&#xD;
&#xD;
          -  Willingness to take part in the study, and consent to the study protocol signed by&#xD;
             parent/guardian or older child (when appropriate)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants requiring exclusive enteral tube feeding&#xD;
&#xD;
          -  Participants on parenteral nutrition&#xD;
&#xD;
          -  Participants with cow's milk or soy allergy or lactose intolerance&#xD;
&#xD;
          -  Participants with galactosaemia&#xD;
&#xD;
          -  Participants with a chronic renal or liver disease&#xD;
&#xD;
          -  Participants who are acutely unwell&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elsa Brando</last_name>
    <phone>+44 01843448538</phone>
    <email>elsab@anaiahhealthcare.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brighton &amp; Sussex NHS Trust</name>
      <address>
        <city>Brighton</city>
        <zip>BN2 5BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chris Smith</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Leeds Children's Hospital,</name>
      <address>
        <city>Leeds</city>
        <zip>LS2 9NS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jacqueline Lowdon</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Graeme O'Connor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Child Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan</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/NCT04488718
org study id: ESj-01
nct id: NCT04488718
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to gather data on the tolerance and acceptability of a new ONS
      (ESj-powder complete) in children currently taking ONS.
The goal of this study is to demonstrate the tolerance and acceptability of the test product
      when consumed by children who are currently prescribed (a similar) ONS. The data generated
      from this study will be submitted to the ACBS, who will consider it for reimbursement as a
      Food for Special Medical Purpose (FSMP) in the UK.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability & Tolerance: questionnaire
time frame: 7 days
description: Acceptability of test product will be tested in children using a questionnaire with a liking scale (Liking Scale - 1-10 - 0 being dislike and 10 being like a lot) and compliance (intake/day versus prescribed dose) of the test product over a 7 day period and compared to acceptability when consuming their current oral nutritional supplement
measure: Gastrointestinal Tolerance
time frame: 7 days
description: Gastrointestinal (GI) tolerance of test product will be determined in children using a questionnaire detailing daily bowel habits and symptoms that occur (new or worsening) while consuming the test product over a 7 day period and compared to GI tolerance when consuming their current oral nutritional supplement. This is established using a combination of the Bristol Stool Chart scoring (BSC - type 1 up to type 7) before and during the study along with number of bowel movements/day and stool consistency.
arm group label: EnergieShake® Junior Powder Complete (test)
arm group type: Experimental
description: EnergieShake® Junior Powder Complete will be consumed by children, as a supplement to normal diet, over a period of 7 day period to determine its acceptability (liking, compliance) and tolerance (gastro-intestinal tolerance). The dose will be the same as currently consumed product (all children recruited to the study will be consuming an oral nutritional supplement).
intervention type: Other
intervention name: EnergieShake® Junior Powder Complete
description: Oral Nutritional Supplement
arm group label: EnergieShake® Junior Powder Complete (test)
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Elsa Brando
phone: +44 01843448538
email: elsab@anaiahhealthcare.com
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Nutrition Disorders
mesh term: Child Nutrition Disorders
sharing ipd: No
ipd description: no plan