Status:
COMPLETED
Tolerance and Acceptability Evaluation of STOCKHOLM
Lead Sponsor:
Aymes International Limited
Conditions:
Malnutrition
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.
Detailed Description
To evaluate tolerance and acceptability of 'STOCKHOLM' in patients requiring supplementary oral nutritional support compared with currently available alternatives. To obtain data to support an ACBS s...
Eligibility Criteria
Inclusion
- Patients who are able to communicate their views regarding acceptability.
- Patients established on an oral nutritional supplement, being prescribed ONS providing approximately 300 kcal/day
- Patients expected to require oral nutritional supplementation for at least 2 further weeks.
- Informed consent obtained.
Exclusion
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- Patients requiring a milk free diet
- Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
- Patients with significant renal or hepatic impairment
- Patients with dysphagia requiring stage 1,2 or 3 thickened fluids
- Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
Key Trial Info
Start Date :
November 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03844373
Start Date
November 2 2018
End Date
December 1 2020
Last Update
January 6 2021
Active Locations (1)
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1
Gemma Fry
Haywards Heath, United Kingdom, RH16 9PL