Tolerance and Acceptability Evaluation AYMES Cardiff

Tolerance and Acceptability Evaluation AYMES Cardiff

To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.

To obtain data to support an ACBS submissions for 'CARDIFF' (to allow for prescription in the community at NHS expense).

Inclusion Criteria:

• Male and female patients.
• ≥ 18 years of age.
• Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 30 days.
• Patient is able and willing to provide written informed consent.

Exclusion Criteria:

• Patients with medical or dietary contraindication to any feed ingredients.
• Patients requiring sole enteral tube feeding or parenteral nutrition.
• Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.)
• Patients with dysphagia requiring levels 1, 2, 3 or 4 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 2 weeks prior to entry into the study.