Tolerance and Acceptability Evaluation of STOCKHOLM

Aymes International

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: STOCKHOLM

Study type: Interventional

Funder types: Industry

Identifiers

NCT03844373

AY:APL:OPD

Details and patient eligibility

About

Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.

Full 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 submissions for 'STOCKHOLM' (to allow for prescription in the community at NHS expense).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental

Experimental group

Description:

Patients established on an oral nutritional supplement, being prescribed oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of STOCKHOLM for a period of 9 days.

Treatment:

Dietary Supplement: STOCKHOLM