Bolus Pouch Feed Study
- Conditions
- Neurological DisorderOral ComplicationGastrointestinal DysfunctionCancerStroke
- Interventions
- Other: Bolus Pouch Feed
- Registration Number
- NCT05822557
- Lead Sponsor
- Nutricia UK Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- ≥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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bolus Pouch Feed Bolus Pouch Feed A 250 ml feeding pouch containing 400 kcal.
- Primary Outcome Measures
Name Time Method Health and feeding related quality of life Baseline to end of intervention (Day 35) 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.
- Secondary Outcome Measures
Name Time Method Ease of administration Baseline to end of intervention (Day 35) At baseline, and at the mid-point and end of the intervention period, patients and dietitians will be asked to rate the ease of administering the enteral tube feed via a Likert-style questionnaire. Patients will also count the amount of feeding equipment required to administer the enteral feed at baseline, and at the midpoint and end of the intervention period.
Gastrointestinal tolerance Baseline to end of intervention (Day 35) A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded at the end of each week. Information about bowel movements will also be collected using the Bristol Stool Chart©.
Liking of feeding method Baseline to end of intervention (Day 35) At baseline, and at the mid-point and end of the intervention period, patients will be asked to rate their liking of their usual feeding method or of the intervention feed, respectively via a 7-point Likert scale questionnaire.
Nutrient intake Baseline to end of intervention (Day 35) At baseline, and at the mid-point and end of the intervention period, the dietitian will conduct a 24-h dietary recall with the patient to record all food, drink and nutritional feeds provided in the 24 h prior. Trained research staff will subsequently analyse all records utilising a nutritional software package (Nutritics Professional v3.09, Nutritics, Ireland) for macro- and micro-nutrient intakes.
Adverse Events Baseline to end of intervention (Day 35) All adverse events will be recorded throughout the study.
Compliance Baseline to end of intervention (Day 35) Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the patient.
Body weight (kg) Baseline to end of intervention (Day 35) At baseline and at the end of the intervention period, body weight (kg) will be measured using standard methods to the nearest 0.1 kg using a weighing scale without heavy clothing.
Trial Locations
- Locations (15)
University Hospitals Sussex NHS Foundation Trust
🇬🇧Brighton, United Kingdom
Betsi Cadwaladr University Health Board
🇬🇧Holywell, United Kingdom
Leicestershire Partnership NHS Trust
🇬🇧Leicester, United Kingdom
Calderdale & Huddersfield NHS Foundation Trust
🇬🇧Huddersfield, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, 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
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
Northumbria Healthcare NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
🇬🇧Coventry, United Kingdom
North East London NHS Foundation Trust
🇬🇧London, United Kingdom