At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Plant-protein dominant enteral feed (supplement), Animal-protein dominant enteral feed (supplement)
- How long the study runs
- Study runs about 30 months (dates as stated)
- About the drug or intervention
- Plant-protein dominant enteral feed — supplement: Patients randomised to the Intervention Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 plant-protein dominant enteral feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. · Animal-protein dominant enteral feed — supplement: Patients randomised to the Control Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 animal-protein dominant control feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 110
- Started
- 2026-01-01
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for enteral nutrition (food for special medical purposes)
- • NA - 110 participants
- • This study aims to determine whether a reformulated plant-protein dominant protein blend in four existing enteral tube feeds is as effective as animal-protein dominant formulations in patients who are tube fed at home
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with enteral nutrition (food for special medical purposes)
Where?
- • Trowbridge - Nutricia Ltd
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study aims to determine whether a reformulated plant-protein dominant protein blend in four existing enteral tube feeds is as effective as animal-protein dominant formulations in patients who are tube fed at home. This is an exploratory randomised, controlled, trial with a 3-day baseline period. Adult home tube feeding patients will be randomised to receive either a plant-protein dominant formulation or a control product (an animal-protein dominant formulation) for a 3-month intervention period followed by a 6-month and 12-month follow-up. The outcomes include gastrointestinal tolerance, compliance, acceptability, anthropometry, nutrient intake, and physical function
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
What the study is looking for
- ✓Male or female
- ✓≥16 years of age
- ✓Using or requiring an enteral tube feed in the community as part of nutritional management plan
- ✓Expected to receive at least 500ml (≥500kcal) per day from one of the study products
Who cannot take part
- ✗Receiving parenteral nutrition
- ✗Patients with major liver dysfunction (i.e., decompensated liver disease)
- ✗Patients with major kidney dysfunction (i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD))
- ✗Patients receiving inpatient care
- ✗Known pregnancy or lactation
See the full criteria
Where Is This Study? (1 UK site)
Nutricia Ltd
Trowbridge BA14 0XQ, United Kingdom
How to Get in Touch
Sophie Bell
Sponsor contactCONTACT
Marta Delsoglio
Sponsor contactCONTACT