Bolus Pouch Feed Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke, Cancer, Neurological Disorder, Gastrointestinal Dysfunction, Oral Complication

Intervention / Treatment
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* Other: Bolus Pouch Feed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolus Pouch Feed<br>A 250 ml feeding pouch containing 400 kcal. | Other: Bolus Pouch Feed<br>* 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<br>|

What is the study measuring?
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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) |