Madrid - Tolerance and Acceptability Study

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Other: AYMES MADRID

• Registration Number: NCT03834896
• Lead Sponsor: Aymes International Limited

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).

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-07
• Last Update Submitted: 2019-02-07
• Study First Posted: 2019-02-08
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	AYMES MADRID	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.

Primary Outcome Measures

Name	Time	Method
GI side effects when using AYMES MADRID	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

Name	Time	Method
Compliance with prescription of AYMES MADRID	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
Bowel habits of subjects when using AYMES MADRID - frequency	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.
Bowel habits of subjects when using AYMES MADRID - stool consistency	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

Trial Locations

Locations (1)

AYMES International Ltd.; 🇬🇧 Haywards Heath, United Kingdom