xml: <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/NCT06034951</url>
    </required_header>
    <id_info>
      <org_study_id>Compleat002</org_study_id>
      <nct_id>NCT06034951</nct_id>
    </id_info>
    <brief_title>Acceptability and Tolerance Study of a High Energy Tube Feed With Food Derived Ingredients</brief_title>
    <official_title>Acceptability (Including Gastrointestinal Tolerance and Compliance) of a High Energy, Adult Enteral Formula With Food-derived Ingredients.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Société des Produits Nestlé (SPN)</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Société des Produits Nestlé (SPN)</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>
        Enterally fed adults and children who are assessed by the dietitian as requiring an adult&#xD;
        high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants&#xD;
        are required in order to submit an application to the Advisory Committee on Borderline&#xD;
        Substances (ACBS) for product registration.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high&#xD;
        energy, adult enteral formula with food-derived ingredients.This is a single arm,&#xD;
        prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance&#xD;
        over a 14-day period with the new tube feed.&#xD;
  &#xD;
        Participants or their caregivers will be provided with 14-day supply of the new tube feed and&#xD;
        will be asked to complete a daily diary and short questionnaire to record information&#xD;
        allowing assessment of the following:&#xD;
  &#xD;
          -  Gastrointestinal tolerance&#xD;
  &#xD;
          -  Compliance with prescribed feed volume&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 24, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Actual">August 21, 2023</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>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Daily patient diaries</measure>
      <time_frame>14 days</time_frame>
      <description>Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily formula intake</measure>
      <time_frame>14 days</time_frame>
      <description>mL per day</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Tolerance</condition>
    <arm_group>
      <arm_group_label>Patients well established on tube feeds will act as their own control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>These patients will switch from current to new tube feed to assess acceptability and tolerance</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Compleat 1.5 HP</intervention_name>
      <description>Patients well established and stable on an enteral tube feed. This group will act as their own controls and switched to the new tube feed.</description>
      <arm_group_label>Patients well established on tube feeds will act as their own control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients requiring an enteral tube feed (taking &gt; 60% of energy needs from their&#xD;
               feeding tube) as part of their dietary management for disease related malnutrition&#xD;
  &#xD;
                 -  Children 15 years and over&#xD;
  &#xD;
                 -  Adults and children requiring an adult high-energy and fibre-containing formula,&#xD;
                    as assessed by the dietitian.&#xD;
  &#xD;
                 -  Patients well-established and stable on enteral feeding.&#xD;
  &#xD;
                 -  Willingly given, written, informed consent from patient or consultee&#xD;
  &#xD;
                 -  Willingly given, written assent (if appropriate).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to comply with the study protocol, in the opinion of the investigator&#xD;
  &#xD;
                 -  Children under 15 years of age&#xD;
  &#xD;
                 -  Patients receiving mechanical ventilation, sedation or inotropic support&#xD;
  &#xD;
                 -  Patients on total parenteral nutrition&#xD;
  &#xD;
                 -  Known food allergies to any ingredients (see ingredients list) or galactosaemia&#xD;
  &#xD;
                 -  Patients with significant renal or hepatic impairment&#xD;
  &#xD;
                 -  Patients with planned changes to medication or treatments during the study period&#xD;
                    which may alter gastrointestinal function (e.g. chemotherapy). Changes in&#xD;
                    medications or nutritional products during the study intervention must be&#xD;
                    documented.&#xD;
  &#xD;
                 -  Participation in another interventional study within 2 weeks of this study.&#xD;
  &#xD;
                 -  Patients with a clinical indication for a low fibre or fibre free diet as advised&#xD;
                    by the healthcare team.&#xD;
  &#xD;
                 -  Patients with known or suspected ileus or mechanical bowel obstruction&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Martha Van Der Linde</last_name>
      <role>Principal Investigator</role>
      <affiliation>Community Paediatric Dietitian Worcestershire North Nutrition and Dietetic Hastings Way, Worcester. UK</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Amy Carter</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Walton Centre NHS Foundation Trust, Liverpool UK</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sam Ogundere</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lewisham and Greenwich NHS Trust London UK</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Adrian Gilson</last_name>
      <role>Principal Investigator</role>
      <affiliation>Newham General Hospital London UK</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Saduera</last_name>
      <phone>+447944513233</phone>
      <email>sharan.saduera@uk.nestle.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Martha Van Der Linde</last_name>
      <phone>07717530359</phone>
      <email>martha.vanderlinde@nhs.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Martha Van Der Linde</name>
        <address>
          <city>Worcester</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Martha Van Der Linde</last_name>
        <phone>07717530359</phone>
        <email>martha.vanderlinde@nhs.net</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Abstract and full publication to be made available at the next nutrition and dietetic medical conference</ipd_description>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034951
  org study id: Compleat002
  nct id: NCT06034951
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Enterally fed adults and children who are assessed by the dietitian as requiring an adult
        high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants
        are required in order to submit an application to the Advisory Committee on Borderline
        Substances (ACBS) for product registration.
  To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high
        energy, adult enteral formula with food-derived ingredients.This is a single arm,
        prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance
        over a 14-day period with the new tube feed.
  
        Participants or their caregivers will be provided with 14-day supply of the new tube feed and
        will be asked to complete a daily diary and short questionnaire to record information
        allowing assessment of the following:
  
          -  Gastrointestinal tolerance
  
          -  Compliance with prescribed feed volume
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Daily patient diaries
  time frame: 14 days
  description: Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change
  measure: Daily formula intake
  time frame: 14 days
  description: mL per day
  arm group label: Patients well established on tube feeds will act as their own control
  arm group type: Other
  description: These patients will switch from current to new tube feed to assess acceptability and tolerance
  intervention type: Dietary Supplement
  intervention name: Compleat 1.5 HP
  description: Patients well established and stable on an enteral tube feed. This group will act as their own controls and switched to the new tube feed.
  arm group label: Patients well established on tube feeds will act as their own control
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Martha Van Der Linde
  role: Principal Investigator
  affiliation: Community Paediatric Dietitian Worcestershire North Nutrition and Dietetic Hastings Way, Worcester. UK
  last name: Amy Carter
  role: Principal Investigator
  affiliation: The Walton Centre NHS Foundation Trust, Liverpool UK
  last name: Sam Ogundere
  role: Principal Investigator
  affiliation: Lewisham and Greenwich NHS Trust London UK
  last name: Adrian Gilson
  role: Principal Investigator
  affiliation: Newham General Hospital London UK
  last name: Saduera
  phone: +447944513233
  email: sharan.saduera@uk.nestle.com
  last name: Martha Van Der Linde
  phone: 07717530359
  email: martha.vanderlinde@nhs.net
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Abstract and full publication to be made available at the next nutrition and dietetic medical conference
  ipd info type: Clinical Study Report (CSR)