Bolus Pouch Feed Study

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822557
• Other study ID #: BOPFS2020
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: January 25, 2024

Study information

• Verified date: April 2024
• Source: Nutricia UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Gastrointestinal Dysfunction
• Nervous System Diseases
• Neurological Disorder
• Oral Complication
• Stroke

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia UK Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Adverse Events	All adverse events will be recorded throughout the study.	Baseline to end of intervention (Day 35)