<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/NCT04399954</url>
  </required_header>
  <id_info>
    <org_study_id>MCT-KFLO-2018-02-19</org_study_id>
    <secondary_id>232386</secondary_id>
    <secondary_id>19/NW/0018</secondary_id>
    <nct_id>NCT04399954</nct_id>
  </id_info>
  <brief_title>Evaluation of Ketoflo</brief_title>
  <acronym>Ketoflo</acronym>
  <official_title>A Study to Evaluate the Acceptability of Ketoflo, a Food for Special Medical Purposes (FSMP) for Use in the Dietary Management of Epilepsy or Neurometabolic Conditions Requiring a Ketogenic Diet (KD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vitaflo International, Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vitaflo International, Ltd</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>
      For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring&#xD;
      a ketogenic diet will incorporate Ketoflo into their usual dietary regime. Ketoflo is a&#xD;
      nutritionally complete Food For Special Medical Purposes and is suitable for administration&#xD;
      by both tube feeding and use as a sip feed. Data on gastrointestinal tolerance, participants&#xD;
      adherence to recommended intakes and their thoughts on the product's palatability will be&#xD;
      self-reported in Daily Study Diaries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 28-day prospective study to evaluate the acceptability of Ketoflo, in terms of GI&#xD;
      tolerance, adherence to recommended intakes and palatability. The product's nutritional&#xD;
      suitability for use in a ketogenic diet will also be evaluated by recording ketone levels and&#xD;
      seizure frequency measured as part of usual clinical care.&#xD;
&#xD;
      Ketoflo is nutritionally complete liquid feed for use in the dietary management of epilepsy&#xD;
      or other neurometabolic conditions requiring a ketogenic diet. It is designed to be&#xD;
      nutritionally complete from 3-18 years and can be used as a supplementary feed thereafter.&#xD;
&#xD;
      Ketoflo has been designed in liaison with Key Opinion Leaders and will offer an additional&#xD;
      choice of prescribe-able feeds for use in the ketogenic diet.&#xD;
&#xD;
      The study will involve 30 participants, aged between three and eighteen years of age&#xD;
      (inclusive), who are already established on a ketogenic diet for at least three months before&#xD;
      the study begins.&#xD;
&#xD;
      Participants will self-report data in Daily Study Diaries over the course of the study. Data&#xD;
      will also be collected by the Investigators in Baseline CRFs and End of Study CRFs for all&#xD;
      participants. Any data collected for the study will be anonymised before being relayed to the&#xD;
      sponsor.&#xD;
&#xD;
      The data generated by the trial will be used to support a submission by Vitaflo&#xD;
      (International) Ltd. to the Advisory Committee on Borderline Substances (ACBS) for Ketoflo to&#xD;
      become reimbursable on prescription in the UK. The data will also be used in a submission to&#xD;
      the General Medical Services in the Republic of Ireland.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 24, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2024</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>
    <intervention_model_description>Single group - all patients to receive Ketoflo.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking, product will be given open label.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in gastrointestinal tolerance from week 1 to week 4</measure>
    <time_frame>Days 1 - 7 and days 21 - 28.</time_frame>
    <description>Participants will self-report any gastrointestinal symptoms experienced over the course of the study in Daily Study Diaries.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence</measure>
    <time_frame>Days 1 - 28.</time_frame>
    <description>Participants will record the amount of Ketoflo taken each day compared to the amount recommended by their dietitian.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Palatability and ease of use</measure>
    <time_frame>Day 28.</time_frame>
    <description>Participants will answer questions relating to Ketoflo's palatability and ease of use following the end of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutritional suitability: ketone levels</measure>
    <time_frame>Days 1 - 28</time_frame>
    <description>Ketoflo's nutritional suitability will be assessed by evaluating ketone levels (mmol/l) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutritional suitability: seizure frequency</measure>
    <time_frame>Days 1 - 28</time_frame>
    <description>Ketoflo's nutritional suitability will be assessed by evaluating seizure frequency (number per day) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Epilepsy Intractable</condition>
  <condition>Glucose Transporter Type 1 Deficiency Syndrome</condition>
  <condition>Ketogenic Dieting</condition>
  <arm_group>
    <arm_group_label>Ketoflo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ketoflo to be incorporated into each participant's usual ketogenic diet for 28 days. Amount taken and frequency of intake to be determined by the dietitian.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ketoflo</intervention_name>
    <description>Ketoflo is a ready to use liquid feed for the dietary management of epilepsy and other conditions that may require a ketogenic diet. It has a 4:1 ratio of fat to carbohydrate and protein and can be administered enterally via a tube feeding or oral consumption.</description>
    <arm_group_label>Ketoflo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i) Diagnosis of a condition requiring a ketogenic diet (KD) e.g. intractable epilepsy,&#xD;
        Glut-1 deficiency syndrome (Glut-1 DS) etc.&#xD;
&#xD;
        ii) Aged 3 - 18 years of age (inclusive).&#xD;
&#xD;
        iii) Established on a ketogenic diet for at least 3 months under the supervision of a&#xD;
        clinician and/or dietitian trained in the use of the KD.&#xD;
&#xD;
        iv) Requirement for a liquid ketogenic feed.&#xD;
&#xD;
        v) In the opinion of the investigator, the participant (and parent/guardian, if relevant)&#xD;
        is/are able to comply with the study protocol requirements and complete the diary and&#xD;
        questionnaire.&#xD;
&#xD;
        vi) Willingly given, written, informed consent from participant (or parent/guardian, if&#xD;
        relevant)&#xD;
&#xD;
        vii) Willingly given, written assent (if appropriate).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i) Inability to comply with the study protocol, in the opinion of the investigator.&#xD;
&#xD;
        ii) Under 3 years of age or over 18 years of age.&#xD;
&#xD;
        iii) Medical conditions in which the KD is contraindicated.&#xD;
&#xD;
        iv) Previous clinical evaluation indicating unsuitability for the KD.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn Lightfoot</last_name>
    <role>Study Director</role>
    <affiliation>Leeds Teaching Hospitals NHS Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Victoria Whiteley</last_name>
    <role>Principal Investigator</role>
    <affiliation>Manchester University NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Grace Thomas</last_name>
    <phone>01517099020</phone>
    <email>Grace.Thomas@Vitaflo.co.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Erika Brennan</last_name>
    <phone>1517099020</phone>
    <phone_ext>262</phone_ext>
    <email>Erika.Brennan@vitaflo.co.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Aberdeen Children's Hospital</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tracey Cameron</last_name>
      <email>Tracey.Cameron1@NHS.Scot</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Barberry</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manny Bagary</last_name>
      <email>M.Bagary@NHS.Net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Hospital for Children</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Camille Newby</last_name>
      <email>Camille.Newby@UHBW.NHS.UK</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tayside Children's Hospital</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tracey Cameron</last_name>
      <email>Tracey.Cameron1@NHS.Scot</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Leeds Children's Hospital</name>
      <address>
        <city>Leeds</city>
        <zip>LS1 3EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathryn Lightfoot</last_name>
      <email>Kathryn.Lightfoot@NHS.Net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital for Children</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zoe Simpson</last_name>
      <email>Zoe.Simpson@GOSH.NHS.UK</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</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>Epilepsy</mesh_term>
    <mesh_term>Drug Resistant Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans to share IPD.</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/NCT04399954
org study id: MCT-KFLO-2018-02-19
secondary id: 232386
secondary id: 19/NW/0018
nct id: NCT04399954
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring
      a ketogenic diet will incorporate Ketoflo into their usual dietary regime. Ketoflo is a
      nutritionally complete Food For Special Medical Purposes and is suitable for administration
      by both tube feeding and use as a sip feed. Data on gastrointestinal tolerance, participants
      adherence to recommended intakes and their thoughts on the product's palatability will be
      self-reported in Daily Study Diaries.
This is a 28-day prospective study to evaluate the acceptability of Ketoflo, in terms of GI
      tolerance, adherence to recommended intakes and palatability. The product's nutritional
      suitability for use in a ketogenic diet will also be evaluated by recording ketone levels and
      seizure frequency measured as part of usual clinical care.

      Ketoflo is nutritionally complete liquid feed for use in the dietary management of epilepsy
      or other neurometabolic conditions requiring a ketogenic diet. It is designed to be
      nutritionally complete from 3-18 years and can be used as a supplementary feed thereafter.

      Ketoflo has been designed in liaison with Key Opinion Leaders and will offer an additional
      choice of prescribe-able feeds for use in the ketogenic diet.

      The study will involve 30 participants, aged between three and eighteen years of age
      (inclusive), who are already established on a ketogenic diet for at least three months before
      the study begins.

      Participants will self-report data in Daily Study Diaries over the course of the study. Data
      will also be collected by the Investigators in Baseline CRFs and End of Study CRFs for all
      participants. Any data collected for the study will be anonymised before being relayed to the
      sponsor.

      The data generated by the trial will be used to support a submission by Vitaflo
      (International) Ltd. to the Advisory Committee on Borderline Substances (ACBS) for Ketoflo to
      become reimbursable on prescription in the UK. The data will also be used in a submission to
      the General Medical Services in the Republic of Ireland.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group - all patients to receive Ketoflo.
primary purpose: Supportive Care
masking: None (Open Label)
masking description: No masking, product will be given open label.
measure: Change in gastrointestinal tolerance from week 1 to week 4
time frame: Days 1 - 7 and days 21 - 28.
description: Participants will self-report any gastrointestinal symptoms experienced over the course of the study in Daily Study Diaries.
measure: Adherence
time frame: Days 1 - 28.
description: Participants will record the amount of Ketoflo taken each day compared to the amount recommended by their dietitian.
measure: Palatability and ease of use
time frame: Day 28.
description: Participants will answer questions relating to Ketoflo's palatability and ease of use following the end of the study.
measure: Nutritional suitability: ketone levels
time frame: Days 1 - 28
description: Ketoflo's nutritional suitability will be assessed by evaluating ketone levels (mmol/l) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.
measure: Nutritional suitability: seizure frequency
time frame: Days 1 - 28
description: Ketoflo's nutritional suitability will be assessed by evaluating seizure frequency (number per day) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.
arm group label: Ketoflo
arm group type: Experimental
description: Ketoflo to be incorporated into each participant's usual ketogenic diet for 28 days. Amount taken and frequency of intake to be determined by the dietitian.
intervention type: Dietary Supplement
intervention name: Ketoflo
description: Ketoflo is a ready to use liquid feed for the dietary management of epilepsy and other conditions that may require a ketogenic diet. It has a 4:1 ratio of fat to carbohydrate and protein and can be administered enterally via a tube feeding or oral consumption.
arm group label: Ketoflo
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Kathryn Lightfoot
role: Study Director
affiliation: Leeds Teaching Hospitals NHS Trust
last name: Victoria Whiteley
role: Principal Investigator
affiliation: Manchester University NHS Foundation Trust
last name: Grace Thomas
phone: 01517099020
email: Grace.Thomas@Vitaflo.co.uk
last name: Erika Brennan
phone: 1517099020
phone ext: 262
email: Erika.Brennan@vitaflo.co.uk
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Drug Resistant Epilepsy
sharing ipd: No
ipd description: No plans to share IPD.