<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/NCT03834896</url>
  </required_header>
  <id_info>
    <org_study_id>AY:ST2</org_study_id>
    <nct_id>NCT03834896</nct_id>
  </id_info>
  <brief_title>Madrid - Tolerance and Acceptability Study</brief_title>
  <official_title>Madrid - Tolerance and Acceptability Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aymes International Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aymes International Limited</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>
      Tolerance and Acceptability of a gum based thickener.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the tolerance and acceptability of AYMES MADRID, in patients that may require&#xD;
      modified consistency fluids. Measuring GI tolerance, compliance, convenience and preference.&#xD;
&#xD;
      To obtain data to support an ACBS submissions for AYMES MADRID (to allow for prescription in&#xD;
      the community at NHS expense).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GI side effects when using AYMES MADRID</measure>
    <time_frame>9 Days</time_frame>
    <description>Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES MADRID as assessed by presence / absence of side effect compared to baseline period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance with prescription of AYMES MADRID</measure>
    <time_frame>9</time_frame>
    <description>Recording of amount of AYMES PARIS consumed by subjects compared to amount prescribed. Good compliance = &gt;80% of prescribed being consumed. Same data collected for baseline product and compared with that of AYMES MADRID</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel habits of subjects when using AYMES MADRID - frequency</measure>
    <time_frame>9 days</time_frame>
    <description>Recording of bowel habits whilst subjects consuming AYMES MADRID, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel habits of subjects when using AYMES MADRID - stool consistency</measure>
    <time_frame>9 days</time_frame>
    <description>Recording of bowel habits whilst subjects consuming AYMES MADRID, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Dysphagia</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by Speech and Language Therapist and who are expected to require provision of Stage 1, 2 or 3 thickened fluids for at least 2 further weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AYMES MADRID</intervention_name>
    <description>AYMES MADRID is a gum-based commercial thickener, that can be utilised to modify fluid consistencies to Stage 1, 2 or 3 (as per the National Descriptors for Texture Modification) to enhance the safety of fluids in those with dysphagia.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (≥18 years) who are able to communicate clearly.&#xD;
&#xD;
          -  Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by&#xD;
             -Speech and Language Therapist.&#xD;
&#xD;
          -  Patients expected to require provision of Stage 1, 2 or 3 thickened fluids for at&#xD;
             least 2 further weeks.&#xD;
&#xD;
          -  Informed consent obtained from patient or for those without capacity following&#xD;
             consultation with carers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with maize / corn allergy requiring a maize free diet&#xD;
&#xD;
          -  Patients with inherited metabolic conditions.&#xD;
&#xD;
          -  Patients requiring enteral tube feeding or parenteral nutrition.&#xD;
&#xD;
          -  Patients with medical or dietary contraindication to any feed ingredients&#xD;
&#xD;
          -  Patients with delayed oral phase of swallowing.&#xD;
&#xD;
          -  Patients with significant renal (requiring dialysis) or hepatic impairment (e.g.&#xD;
             hepatitis)&#xD;
&#xD;
          -  Patients with dysphagia not requiring stage 1, 2 or 3 thickened fluids.&#xD;
&#xD;
          -  Patients with uncontrolled inflammatory bowel disease or previous bowel resection with&#xD;
             ongoing gastrointestinal symptoms.&#xD;
&#xD;
          -  Patients for whom the investigator has concerns regarding the ability or willingness&#xD;
             of the patient and or carer to comply with protocol requirements&#xD;
&#xD;
          -  Participation in any other studies involving investigational or marketed products&#xD;
             concomitantly or within two weeks prior to entry into the study (to prevent over&#xD;
             burdening of participants and ensure a period of normalisation between study&#xD;
             involvement)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AYMES International Ltd.</name>
      <address>
        <city>Haywards Heath</city>
        <zip>RH16 9PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</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>Deglutition Disorders</mesh_term>
  </condition_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/NCT03834896
org study id: AY:ST2
nct id: NCT03834896
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Tolerance and Acceptability of a gum based thickener.
To evaluate the tolerance and acceptability of AYMES MADRID, in patients that may require
      modified consistency fluids. Measuring GI tolerance, compliance, convenience and preference.

      To obtain data to support an ACBS submissions for AYMES MADRID (to allow for prescription in
      the community at NHS expense).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: GI side effects when using AYMES MADRID
time frame: 9 Days
description: Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES MADRID as assessed by presence / absence of side effect compared to baseline period.
measure: Compliance with prescription of AYMES MADRID
time frame: 9
description: Recording of amount of AYMES PARIS consumed by subjects compared to amount prescribed. Good compliance = >80% of prescribed being consumed. Same data collected for baseline product and compared with that of AYMES MADRID
measure: Bowel habits of subjects when using AYMES MADRID - frequency
time frame: 9 days
description: Recording of bowel habits whilst subjects consuming AYMES MADRID, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period.
measure: Bowel habits of subjects when using AYMES MADRID - stool consistency
time frame: 9 days
description: Recording of bowel habits whilst subjects consuming AYMES MADRID, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period
arm group label: Experimental
arm group type: Experimental
description: Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by Speech and Language Therapist and who are expected to require provision of Stage 1, 2 or 3 thickened fluids for at least 2 further weeks.
intervention type: Other
intervention name: AYMES MADRID
description: AYMES MADRID is a gum-based commercial thickener, that can be utilised to modify fluid consistencies to Stage 1, 2 or 3 (as per the National Descriptors for Texture Modification) to enhance the safety of fluids in those with dysphagia.
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Deglutition Disorders
sharing ipd: No