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Madrid - Tolerance and Acceptability Study

Primary Purpose

Dysphagia

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

AYMES MADRID

About this trial

This is an interventional other trial for Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

AYMES International Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm 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.

Outcomes

Primary Outcome Measures

GI side effects when using AYMES MADRID

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

Compliance with prescription of AYMES MADRID

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

Bowel habits of subjects when using AYMES MADRID - frequency

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.

Bowel habits of subjects when using AYMES MADRID - stool consistency

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

Full Information

NCT ID

NCT03834896

First Posted

February 6, 2019

Last Updated

February 7, 2019

Sponsor

Aymes International Limited

1. Study Identification

Unique Protocol Identification Number

NCT03834896

Brief Title

Madrid - Tolerance and Acceptability Study

Official Title

Madrid - Tolerance and Acceptability Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

January 1, 2018 (Actual)

Study Completion Date

January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aymes International Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Tolerance and Acceptability of a gum based thickener.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysphagia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

AYMES MADRID

Intervention 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.

Primary Outcome Measure Information:

Title

GI side effects when using AYMES MADRID

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.

Time Frame

9 Days

Secondary Outcome Measure Information:

Title

Compliance with prescription of AYMES MADRID

Description

Time Frame

Title

Bowel habits of subjects when using AYMES MADRID - frequency

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.

Time Frame

9 days

Title

Bowel habits of subjects when using AYMES MADRID - stool consistency

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

Time Frame

9 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Facility Information:

Facility Name

AYMES International Ltd.

City

Haywards Heath

ZIP/Postal Code

RH16 9PL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

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