NCT05822557Completed
Bolus Pouch Feed Study
A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults
Source: ClinicalTrials.gov · Last updated 26 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 12 Apr 2022
- Start date
- 1 Apr 2023
- Primary completion date
- 25 Jan 2024
- Lead sponsor
- Nutricia UK Ltd
- Diseases
- Stroke, Childhood cancers
- NCT number
- NCT05822557
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 1 Apr 2023 to the primary completion date, 25 Jan 2024
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving inpatient care
Other illness
- Patients with major hepatic dysfunction (i.e., decompensated liver disease)
- Patients with major renal dysfunction \[i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)\]
- Allergy to any study product ingredients
Other
- Parenteral nutrition contributing more than 70% of total energy requirements
- Participation in other clinical intervention studies within 2 weeks of this study
- Adults lacking mental capacity to consent
- Investigator concern regarding ability or willingness of patient to comply with the study requirements.
Who the study is looking for
- ≥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.
Age in the registry: 16 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Sussex NHS Foundation Trust Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| Cambridge University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| University Hospitals Coventry and Warwickshire NHS Trust Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| County Durham and Darlington NHS Foundation Trust Coordinator of this site? Confirm its status | Darlington | United Kingdom | Unknown status |
| NHS Tayside Coordinator of this site? Confirm its status | Dundee | United Kingdom | Unknown status |
| Royal Surrey NHS Foundation Trust Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| Betsi Cadwaladr University Health Board Coordinator of this site? Confirm its status | Holywell | United Kingdom | Unknown status |
| Calderdale & Huddersfield NHS Foundation Trust Coordinator of this site? Confirm its status | Huddersfield | United Kingdom | Unknown status |
| Leicestershire Partnership NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| North East London NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Northumbria Healthcare NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Sheffield Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Southern Health NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| South Warwickshire NHS Foundation Trust Coordinator of this site? Confirm its status | Warwick | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.