Madrid - Tolerance and Acceptability Study

Madrid - Tolerance and Acceptability Study

Tolerance and Acceptability of a gum based thickener.

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).

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)