NCT05822557

Bolus Pouch Feed Study

A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Nutricia UK Ltd · Industry
• Sex: All
• Age: 16 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Bolus enteral tube feeding (termed 'bolus feeding') is an increasingly common method of providing nutritional support to home enterally tube fed (HETF) patients, particularly those who are more active and/or require greater flexibility in their feeding regimen. However, current methods of bolus feeding are complex to administer, messy, may be unhygienic, and require and lead to a significant amount of plastic waste. Therefore, there is a clear need for a simpler and optimised way to provide bolus feeds. The aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life, ease of use, liking, compliance, gastrointestinal tolerance, nutritional intake, anthropometry and safety. This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.

Conditions

• Cancer
• Neurological Disorder
• Gastrointestinal Dysfunction
• Oral Complication
• Stroke

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-01-25
• Completion: 2024-01-25
• First posted: 2023-04-20
• Last updated: 2025-02-26

Locations

15 sites across 1 country: United Kingdom