Bolus Pouch Feed Study
A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults
1 other identifier
interventional
30
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started Apr 2023
Shorter than P25 for not_applicable cancer
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2022
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2024
CompletedFebruary 26, 2025
February 1, 2025
10 months
April 12, 2022
February 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Health and feeding related quality of life
At baseline, and at the mid-point and end of the intervention period, health and feeding related quality of life will be assessed by the FACT-EQ questionnaire.
Baseline to end of intervention (Day 35)
Secondary Outcomes (7)
Ease of administration
Baseline to end of intervention (Day 35)
Liking of feeding method
Baseline to end of intervention (Day 35)
Gastrointestinal tolerance
Baseline to end of intervention (Day 35)
Compliance
Baseline to end of intervention (Day 35)
Nutrient intake
Baseline to end of intervention (Day 35)
- +2 more secondary outcomes
Study Arms (1)
Bolus Pouch Feed
EXPERIMENTALA 250 ml feeding pouch containing 400 kcal.
Interventions
Following the 7-day baseline period, all patients will enter the 28-day intervention period, where they will receive the intervention feed daily. The feed prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management
Eligibility Criteria
You may qualify if:
- ≥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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nutricia UK Ltdlead
Study Sites (15)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rebecca Stratton, PhD
Nutricia UK Ltd
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
April 12, 2022
First Posted
April 20, 2023
Study Start
April 1, 2023
Primary Completion
January 25, 2024
Study Completion
January 25, 2024
Last Updated
February 26, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share