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Plant-Protein Dominant Tube Feed Study

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Mar 2027 → Jul 2028
See other at-risk trials from Nutricia UK Ltd

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Mar 2027 to Jul 2028
    • Collaborators: 10 to 11
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07422935
Lead Sponsor Nutricia UK Ltd
Collaborators: University Hospitals Coventry and Warwickshire NHS Trust, Gateshead Health NHS Foundation Trust, University Hospitals of Derby and Burton NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, University College London Hospitals, South Warwickshire NHS Foundation Trust, Birmingham Community Healthcare NHS, University Hospital Birmingham, Nottingham University Hospitals NHS Trust, Ashford and St. Peter's Hospitals NHS Trust, East of England Community Health and Care NHS Trust
Conditions
(from sponsor)		 Enteral Nutrition (Food for Special Medical Purposes), Enteral Feeds
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov