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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05822557
Other study ID # BOPFS2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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)
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