Madrid - Tolerance and Acceptability Study

Aymes International

Status: Completed

Conditions: Dysphagia

Treatments: Other: AYMES MADRID

Study type: Interventional

Funder types: Industry

Identifiers

NCT03834896

AY:ST2

Details and patient eligibility

About

Tolerance and Acceptability of a gum based thickener.

Full 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).

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Experimental

Experimental group

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.

Treatment:

Other: AYMES MADRID