A multi-centre, single arm study designed to evaluate the gastro-intestinal tolerance and compliance of a standard adult enteral tube feed with food derived ingredients in the United Kingdom.
Objective
The primary objective of the study was to assess the tolerability, acceptability of a whole-protein 1.1 kcal/mL enteral tube feed containing 16% of food derived ingredients and assessing compliance with the new tube feed. Secondary objectives included assessing reported changes to feed tolerance, compliance and a patient satisfaction.
Results
The tolerance study took place between January 2023 to January 2024 where 16/17 participants completed 7 days. No serious adverse events reported. Majority of the participant in the study have neurological conditions such as cerebral palsy, learning difficulties, stroke and brain injury.
Male to female ratio was 11:6. Average age 28 years, the youngest being 8 years and 2 months and the eldest 71 years of age. Average weight 41 kg, height 1.39 meters and average BMI 21 kg.m2. Average volume consumed was 877mLs versus 929mLs prescribed by the dietitians with a compliance rate of 94%.
Conclusion
Compleat® 1.1 kcal/mL was well tolerated by majority of patients, with some experiencing improvements in stool type and consistency. Two participants did experience flatulence and one with additional abdominal pain due to the fibre content in the new trial feed. Suggest a slower infusion for those patients sensitive to fibre.
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Tolerance and compliance clinical trial of a standard adult enteral tube feed with food-derived ingredients
- 11/03/2025
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