Bolus Pouch Feed Study

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Cancer; Gastrointestinal Dysfunction; Neurological Disorder; Oral Complication
• Intervention / Treatment: Other: Bolus Pouch Feed

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corbin Griffen, PhD; Phone Number: +44 7733 361509; Email: corbin.griffen@nutricia.com
• Study Contact Backup: Name: Gary Hubbard, PhD; Phone Number: +44 7738024720; Email: gary.hubbard@nutricia.com

Study Locations

• United Kingdom
  • Brighton, United Kingdom
    • University Hospitals Sussex NHS Foundation Trust
  • Cambridge, United Kingdom
    • Cambridge University Hospitals NHS Foundation Trust
  • Coventry, United Kingdom
    • University Hospitals Coventry and Warwickshire NHS Trust
  • Darlington, United Kingdom
    • County Durham and Darlington NHS Foundation Trust
  • Dundee, United Kingdom
    • NHS Tayside
  • Guildford, United Kingdom
    • Royal Surrey NHS Foundation Trust
  • Holywell, United Kingdom
    • Betsi Cadwaladr University Health Board
  • Huddersfield, United Kingdom
    • Calderdale & Huddersfield NHS Foundation Trust
  • Leicester, United Kingdom
    • Leicestershire Partnership NHS Trust
  • London, United Kingdom
    • North East London NHS Foundation Trust
  • Newcastle Upon Tyne, United Kingdom
    • Northumbria Healthcare NHS Foundation Trust
  • Nottingham, United Kingdom
    • Nottingham University Hospitals Nhs Trust
  • Sheffield, United Kingdom
    • Sheffield Teaching Hospitals NHS Foundation Trust
  • Southampton, United Kingdom
    • Southern Health NHS Foundation Trust
  • Warwick, United Kingdom
    • South Warwickshire NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥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.

Exclusion Criteria:

• Parenteral nutrition contributing more than 70% of total energy requirements
• 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)]
• Patients receiving inpatient care
• Participation in other clinical intervention studies within 2 weeks of this study
• Adults lacking mental capacity to consent
• Allergy to any study product ingredients
• Investigator concern regarding ability or willingness of patient to comply with the study requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bolus Pouch Feed; A 250 ml feeding pouch containing 400 kcal.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health and feeding related quality of life	At baseline, and at the mid-point and end of the intervention period, health and feeding related quality of life will be assessed by the FACT-EQ questionnaire.	Baseline to end of intervention (Day 35)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of administration	At baseline, and at the mid-point and end of the intervention period, patients and dietitians will be asked to rate the ease of administering the enteral tube feed via a Likert-style questionnaire. Patients will also count the amount of feeding equipment required to administer the enteral feed at baseline, and at the midpoint and end of the intervention period.	Baseline to end of intervention (Day 35)
Liking of feeding method	At baseline, and at the mid-point and end of the intervention period, patients will be asked to rate their liking of their usual feeding method or of the intervention feed, respectively via a 7-point Likert scale questionnaire.	Baseline to end of intervention (Day 35)
Gastrointestinal tolerance	A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded at the end of each week. Information about bowel movements will also be collected using the Bristol Stool Chart©.	Baseline to end of intervention (Day 35)
Compliance	Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the patient.	Baseline to end of intervention (Day 35)
Nutrient intake	At baseline, and at the mid-point and end of the intervention period, the dietitian will conduct a 24-h dietary recall with the patient to record all food, drink and nutritional feeds provided in the 24 h prior. Trained research staff will subsequently analyse all records utilising a nutritional software package (Nutritics Professional v3.09, Nutritics, Ireland) for macro- and micro-nutrient intakes.	Baseline to end of intervention (Day 35)
Body weight (kg)	At baseline and at the end of the intervention period, body weight (kg) will be measured using standard methods to the nearest 0.1 kg using a weighing scale without heavy clothing.	Baseline to end of intervention (Day 35)
Adverse Events	All adverse events will be recorded throughout the study.	Baseline to end of intervention (Day 35)

Collaborators and Investigators

• Sponsor: Nutricia UK Ltd
• Investigators: Study Chair: Rebecca Stratton, PhD, Nutricia UK Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: BOPFS2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No