Bolus Pouch Feed Study
Research type
Research Study
Full title
A study evaluating a newly designed nutritional tube feeding pouch for bolus feeding in adults
IRAS ID
290376
Contact name
Rebecca Stratton
Contact email
Sponsor organisation
Nutricia
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Central portfolio management system, 47368
Duration of Study in the UK
2 years, 10 months, 27 days
Research summary
In the UK, approximately 45,000 community-based patients depend on enteral tube feeding for some, or all, of their dietary needs. Without such nutritional support, which is most commonly via specially formulated, nutritionally complete tube feeds, patient health and quality of life (QOL) would be considerably compromised. Bolus enteral tube feeding (termed ‘bolus feeding’) is an increasingly common method of providing nutritional support to home enterally tube fed patients, particularly those who are more active and/or require greater flexibility in their feeding regimen. Bolus feeding provides numerous reported benefits over continuous feeding, including greater flexibility, better replication of mealtimes, increased convenience, improved management of hunger and a potentially lower risk of tube displacement. However, all current methods of bolus feeding require additional equipment such as extension sets, adapters, pumps and syringes which can increase administration complexity, require planning and lead to more plastic waste. Therefore, there is a clear need for a simpler and optimised way to provide bolus feeds. The aim of this multi-centre study is to evaluate the impact of introducing a new enteral tube feed (1.6 kcal/ml) presented in a unique, small volume, ENFit-compatible, squeezy pouch on health and feeding related QOL, ease of use, liking, compliance, gastrointestinal tolerance, nutritional intake, anthropometry and safety in bolus fed patients. This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period. Following screening and recruitment, patients will continue to receive their standard bolus feeding regimen using existing products for 7 days (baseline period). Patients will then receive an enteral tube feed (1.6 kcal/ml) presented in a unique, small volume, ENFit-compatible, squeezable pouch (study feed: Nutrison Bolus) for 28 days. The study will be conducted at hospitals in the UK with long-term enterally fed patients on their case load. \n\n\n
Lay summary of study results:Background: Using the bolus method to enterally tube feed can be messy and time-consuming. This study looked at a new way to provide enteral feeds via a small squeezable pouch.
Study Design: This study tested a new bolus enteral feeding product in a squeezable pouch. Adult patients who were enterally tube fed received at least 250mls of this enteral feed for 28 days after a 7-day baseline was taken on their current feed.
Results: After 28 days of using the new product, patients spent less time enteral tube feeding. Specifically, set-up, administration, and clean-up times were reduced. Patients also experienced better health related quality of life. Most patients found the pouch acceptable and had improved gastrointestinal tolerance. Patients were consistent in using the new product as recommended by their Dietitian.
Conclusion: The pouch improves patient experience and may be useful for managing tube feeding patients.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0414
Date of REC Opinion
6 Jan 2021
REC opinion
Further Information Favourable Opinion