Clinical trial NCT05822557: Bolus Pouch Feed Study
Official title: A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Neurological Disorder
Gastrointestinal Dysfunction
Oral Complication
Stroke
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* ≥16 years of age
* Using or requiring an enteral tube feed as part of nutritional management plan
* Using or about to use bolus tube feeding methods at least once daily
* Expected to receive at least 400 kcal/day from the intervention feed
* Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign.

Exclusion Criteria:

* Parenteral nutrition contributing more than 70% of total energy requirements
* Patients with major hepatic dysfunction (i.e., decompensated liver disease)
* Patients with major renal dysfunction \[i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)\]
* Patients receiving inpatient care
* Participation in other clinical intervention studies within 2 weeks of this study
* Adults lacking mental capacity to consent
* Allergy to any study product ingredients
* Investigator concern regarding ability or willingness of patient to comply with the study requirements.

Primary outcomes:
measure: Health and feeding related quality of life
timeFrame: Baseline to end of intervention (Day 35)
Secondary outcomes:
measure: Ease of administration
timeFrame: Baseline to end of intervention (Day 35)
measure: Liking of feeding method
timeFrame: Baseline to end of intervention (Day 35)
measure: Gastrointestinal tolerance
timeFrame: Baseline to end of intervention (Day 35)
measure: Compliance
timeFrame: Baseline to end of intervention (Day 35)
measure: Nutrient intake
timeFrame: Baseline to end of intervention (Day 35)
measure: Body weight (kg)
timeFrame: Baseline to end of intervention (Day 35)
measure: Adverse Events
timeFrame: Baseline to end of intervention (Day 35)
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
city: Darlington
country: United Kingdom
facility: County Durham and Darlington NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: Guildford
country: United Kingdom
facility: Royal Surrey NHS Foundation Trust
city: Holywell
country: United Kingdom
facility: Betsi Cadwaladr University Health Board
city: Huddersfield
country: United Kingdom
facility: Calderdale & Huddersfield NHS Foundation Trust
city: Leicester
country: United Kingdom
facility: Leicestershire Partnership NHS Trust
city: London
country: United Kingdom
facility: North East London NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southern Health NHS Foundation Trust
city: Warwick
country: United Kingdom
facility: South Warwickshire NHS Foundation Trust
Study officials:
affiliation: Nutricia UK Ltd
name: Rebecca Stratton, PhD
role: STUDY_CHAIR
References: