Spots Global Cancer Trial Database for Bolus Pouch Feed Study
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Trial Identification
Brief Title: Bolus Pouch Feed Study
Official Title: A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults
Study ID: NCT05822557
Interventions
Study Description
Brief Summary: The primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. Secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.
Detailed Description: Bolus enteral tube feeding (termed 'bolus feeding') is an increasingly common method of providing nutritional support to home enterally tube fed (HETF) patients, particularly those who are more active and/or require greater flexibility in their feeding regimen. However, current methods of bolus feeding are complex to administer, messy, may be unhygienic, and require and lead to a significant amount of plastic waste. Therefore, there is a clear need for a simpler and optimised way to provide bolus feeds. The aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life, ease of use, liking, compliance, gastrointestinal tolerance, nutritional intake, anthropometry and safety. This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospitals Sussex NHS Foundation Trust, Brighton, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust, Coventry, , United Kingdom
County Durham and Darlington NHS Foundation Trust, Darlington, , United Kingdom
NHS Tayside, Dundee, , United Kingdom
Royal Surrey NHS Foundation Trust, Guildford, , United Kingdom
Betsi Cadwaladr University Health Board, Holywell, , United Kingdom
Calderdale & Huddersfield NHS Foundation Trust, Huddersfield, , United Kingdom
Leicestershire Partnership NHS Trust, Leicester, , United Kingdom
North East London NHS Foundation Trust, London, , United Kingdom
Northumbria Healthcare NHS Foundation Trust, Newcastle Upon Tyne, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, , United Kingdom
Southern Health NHS Foundation Trust, Southampton, , United Kingdom
South Warwickshire NHS Foundation Trust, Warwick, , United Kingdom
Contact Details
Name: Rebecca Stratton, PhD
Affiliation: Nutricia UK Ltd
Role: STUDY_CHAIR
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