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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
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

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University Hospitals Sussex NHS Foundation Trust
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BrightonUnited KingdomUnknown status
Cambridge University Hospitals NHS Foundation Trust
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CambridgeUnited KingdomUnknown status
University Hospitals Coventry and Warwickshire NHS Trust
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CoventryUnited KingdomUnknown status
County Durham and Darlington NHS Foundation Trust
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DarlingtonUnited KingdomUnknown status
NHS Tayside
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DundeeUnited KingdomUnknown status
Royal Surrey NHS Foundation Trust
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GuildfordUnited KingdomUnknown status
Betsi Cadwaladr University Health Board
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HolywellUnited KingdomUnknown status
Calderdale & Huddersfield NHS Foundation Trust
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HuddersfieldUnited KingdomUnknown status
Leicestershire Partnership NHS Trust
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LeicesterUnited KingdomUnknown status
North East London NHS Foundation Trust
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LondonUnited KingdomUnknown status
Northumbria Healthcare NHS Foundation Trust
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Newcastle upon TyneUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust
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NottinghamUnited KingdomUnknown status
Sheffield Teaching Hospitals NHS Foundation Trust
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SheffieldUnited KingdomUnknown status
Southern Health NHS Foundation Trust
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SouthamptonUnited KingdomUnknown status
South Warwickshire NHS Foundation Trust
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WarwickUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.