Acceptability and Tolerance Study of Peptide Feed With Fibre

Study Overview
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Brief Summary
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Enterally fed adults with documented evidence of gastrointestinal intolerance will be recruited. Participants will be deemed by the investigator as having a clinical indication for enteral feeding with a fibre containing peptide formula. 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 an adult enteral peptide formula containing Partially Hydrolysed Guar Gum (PHGG) fibre in 15 patients. This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a fourteen-day period. Data will be collected using patient diaries to asses changes in GI tolerance and tube feed intake.

Official Title
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To Evaluate the Acceptability (Including Gastrointestinal Tolerance and Compliance) of an Adult Peptide 1.3 kcal/ml Tube-feed Formula Containing Partially Hydrolysed Guar Gum (PHGG) Fibre.

Conditions
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Dietary Exposure

Intervention / Treatment
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* Dietary Supplement: Peptamen 1.3 PHGG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enterally fed adults feeding taking ≥60% of nutritional requirements from enteral nutrition Patients with documented evidence of feeding intolerance or GI symptoms during enteral feeding, and who in the clinical judgement of the supervising dietitian may benefit from a peptide formula with fibre. Aged 18 years and above. Willingly given, written, informed consent from patient Exclusion Criteria: Inability to comply with the study protocol, in the opinion of the investigator 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: 18 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>Patients in the control group will switch from current feed to new tube feed to assess tolerance and acceptability. | Dietary Supplement: Peptamen 1.3 PHGG<br>* The amount of tube feed will be assess by the health Care Professional.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess tolerance via patient diaries | Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating | 14 days | 
| Daily formula intake | mL | 14 days |