- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03844373
Tolerance and Acceptability Evaluation of STOCKHOLM
January 5, 2021 updated by: Aymes International Limited
Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.
Study Overview
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 submissions for 'STOCKHOLM' (to allow for prescription in the community at NHS expense).
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Haywards Heath, United Kingdom, RH16 9PL
- Gemma Fry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
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.
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STOCKHOLM is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GI Tolerance
Time Frame: 9 Days
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To assess gastro-intestinal tolerance of 'STOCKHOLM' in patients in the community requiring oral nutritional supplementation.
Monitoring includes recording the number and consistency of bowel movements as assessed on the Bristol stool form scale, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.
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9 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire
Time Frame: 9 days
|
To assess the acceptability of 'STOCKHOLM' in patients in the community requiring oral nutritional supplementation.
At the end of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new supplement drink.
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9 days
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Compliance with Prescription of STOCKHOLM
Time Frame: 9 days
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Recording of amount of STOCKHOLM consumed by subjects compared to amount prescribed.
Good compliance = >80% of prescribed being consumed.
Same data collected for baseline product and compared with that of STOCKHOLM.
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9 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2018
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
February 6, 2019
First Submitted That Met QC Criteria
February 15, 2019
First Posted (Actual)
February 18, 2019
Study Record Updates
Last Update Posted (Actual)
January 6, 2021
Last Update Submitted That Met QC Criteria
January 5, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AY:APL:OPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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