Status:
COMPLETED
Tolerance and Acceptability Evaluation AYMES ActaGain
Lead Sponsor:
Aymes International Limited
Conditions:
Malnutrition
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate tolerance and acceptability of 'AYMES ActaGain' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Detailed Description
To evaluate tolerance and acceptability of 'AYMES ActaGain' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effect...
Eligibility Criteria
Inclusion
- Male and female patients.
- ≥ 18 years of age.
- Patients of the intended target group (e.g. MUST score ≥ 1, with or at risk of disease related malnutrition) with an anticipated period of nutritional support ≥ 4 weeks.
- 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 chronic renal disease requiring dialysis.
- Patients with liver failure.
- Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
- Patients assessed by a Speech and Language Therapist who require thickened fluids.
- Participation in any other studies that may interfere with this study.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04703881
Start Date
July 1 2020
End Date
October 1 2020
Last Update
January 11 2021
Active Locations (1)
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1
AYMES International Ltd.
Haywards Heath, United Kingdom, RH16 9PL