Acceptability and Tolerance Study of a High Energy Tube Feed With Food Derived Ingredients

Study Overview
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Brief Summary
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Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.

Detailed Description
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To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high energy, adult enteral formula with food-derived ingredients.This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with the new tube feed. Participants or their caregivers will be provided with 14-day supply of the new tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following: Gastrointestinal tolerance Compliance with prescribed feed volume

Official Title
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Acceptability (Including Gastrointestinal Tolerance and Compliance) of a High Energy, Adult Enteral Formula With Food-derived Ingredients.

Conditions
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Tolerance

Intervention / Treatment
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* Dietary Supplement: Compleat 1.5 HP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring an enteral tube feed (taking > 60% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition Children 15 years and over Adults and children requiring an adult high-energy and fibre-containing formula, as assessed by the dietitian. Patients well-established and stable on enteral feeding. Willingly given, written, informed consent from patient or consultee Willingly given, written assent (if appropriate). Exclusion Criteria: Inability to comply with the study protocol, in the opinion of the investigator Children under 15 years of age Patients receiving mechanical ventilation, sedation or inotropic support Patients on total parenteral nutrition Known food allergies to any ingredients (see ingredients list) or galactosaemia Patients with significant renal or hepatic impairment Patients with planned changes to medication or treatments during the study period which may alter gastrointestinal function (e.g. chemotherapy). Changes in medications or nutritional products during the study intervention must be documented. Participation in another interventional study within 2 weeks of this study. Patients with a clinical indication for a low fibre or fibre free diet as advised by the healthcare team. Patients with known or suspected ileus or mechanical bowel obstruction

Ages Eligible for Study
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Minimum Age: 15 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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients well established on tube feeds will act as their own control<br>These patients will switch from current to new tube feed to assess acceptability and tolerance | Dietary Supplement: Compleat 1.5 HP<br>* Patients well established and stable on an enteral tube feed. This group will act as their own controls and switched to the new tube feed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily patient diaries | Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change | 14 days | 
| Daily formula intake | mL per day | 14 days |