Madrid - Tolerance and Acceptability Study

Dysphagia Clinical Trial

Official title:

Madrid - Tolerance and Acceptability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834896
• Other study ID #: AY:ST2
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: February 2019
• Source: Aymes International Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tolerance and Acceptability of a gum based thickener.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dysphagia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	AYMES International Ltd.	Haywards Heath

Sponsors (1)

Lead Sponsor	Collaborator
Aymes International Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 Days
Secondary	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	9
Secondary	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.	9 days
Secondary	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	9 days