Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-04-01
2024-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Bolus Pouch Feed
A 250 ml feeding pouch containing 400 kcal.
Bolus Pouch Feed
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
Interventions
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Bolus Pouch Feed
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
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Inclusion Criteria
* 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
* 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.
16 Years
100 Years
ALL
No
Sponsors
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Nutricia UK Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Stratton, PhD
Role: STUDY_CHAIR
Nutricia UK Ltd
Locations
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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
Countries
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Other Identifiers
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BOPFS2020
Identifier Type: -
Identifier Source: org_study_id
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