Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2020-07-01
2020-10-01
Brief Summary
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Detailed Description
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To obtain data to support an ACBS submissions for 'AYMES ActaGain' (to allow for prescription in the community at NHS expense).
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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AYMES ActaGain
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 will be changed / started on an equivalent prescription of 'AYMES ActaGain' for a period of 30 days.
AYMES ActaGain
AYMES ActaGain is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is designed as a supplement to the diet but can also be used as a sole source of nutrition.
Interventions
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AYMES ActaGain
AYMES ActaGain is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is designed as a supplement to the diet but can also be used as a sole source of nutrition.
Eligibility Criteria
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Inclusion Criteria
* ≥ 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Aymes International Limited
INDUSTRY
Responsible Party
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Locations
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AYMES International Ltd.
Haywards Heath, , United Kingdom
Countries
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Other Identifiers
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AY-ActaGain
Identifier Type: -
Identifier Source: org_study_id
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