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Madrid - Tolerance and Acceptability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834896
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Aymes International Limited

Study Description
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Brief Summary:
Tolerance and Acceptability of a gum based thickener.

Condition or disease Intervention/treatment Phase
Dysphagia Other: AYMES MADRID Not Applicable

Detailed Description:

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Madrid - Tolerance and Acceptability Study
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
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.
 Other: AYMES MADRID
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.


Outcome Measures
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Primary Outcome Measures :
  1. GI side effects when using AYMES MADRID [ Time Frame: 9 Days ]
    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.


Secondary Outcome Measures :
  1. Compliance with prescription of AYMES MADRID [ Time Frame: 9 ]
    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

  2. Bowel habits of subjects when using AYMES MADRID - frequency [ Time Frame: 9 days ]
    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.

  3. Bowel habits of subjects when using AYMES MADRID - stool consistency [ Time Frame: 9 days ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (≥18 years) who are able to communicate clearly.
  • Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by -Speech and Language Therapist.
  • Patients expected to require provision of Stage 1, 2 or 3 thickened fluids for at least 2 further weeks.
  • Informed consent obtained from patient or for those without capacity following consultation with carers.

Exclusion Criteria:

  • Patients with maize / corn allergy requiring a maize free diet
  • Patients with inherited metabolic conditions.
  • Patients requiring enteral tube feeding or parenteral nutrition.
  • Patients with medical or dietary contraindication to any feed ingredients
  • Patients with delayed oral phase of swallowing.
  • Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis)
  • Patients with dysphagia not requiring stage 1, 2 or 3 thickened fluids.
  • Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
  • Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements
  • Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study (to prevent over burdening of participants and ensure a period of normalisation between study involvement)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834896


Locations
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United Kingdom
AYMES International Ltd.
Haywards Heath, United Kingdom, RH16 9PL
Sponsors and Collaborators
Aymes International Limited
More Information
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Responsible Party: Aymes International Limited
ClinicalTrials.gov Identifier: NCT03834896    
Other Study ID Numbers: AY:ST2
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases