Status:
COMPLETED
Tolerance and Acceptability Evaluation AYMES Cardiff
Lead Sponsor:
Aymes International Limited
Conditions:
Malnutrition
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Detailed Description
To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Comp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04703894
Start Date
November 6 2019
End Date
January 13 2020
Last Update
January 11 2021
Active Locations (1)
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1
AYMES International Ltd.
Haywards Heath, United Kingdom, RH16 9PL