Tolerance and Acceptability Evaluation of STOCKHOLM
1 other identifier
interventional
20
1 country
1
Brief Summary
Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2018
CompletedFirst Submitted
Initial submission to the registry
February 6, 2019
CompletedFirst Posted
Study publicly available on registry
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 6, 2021
January 1, 2021
2.1 years
February 6, 2019
January 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
GI Tolerance
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.
9 Days
Secondary Outcomes (2)
Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire
9 days
Compliance with Prescription of STOCKHOLM
9 days
Study Arms (1)
Experimental
EXPERIMENTALPatients 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.
Interventions
STOCKHOLM is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gemma Fry
Haywards Heath, RH16 9PL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2019
First Posted
February 18, 2019
Study Start
November 2, 2018
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
January 6, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share