Acceptability and Tolerance Study of Peptide Feed with Fibre

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-05

Study Completion Date

2024-09-03

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.

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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.

Conditions

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Dietary Exposure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patients well established on tube feeds will act as their own control

Patients in the control group will switch from current feed to new tube feed to assess tolerance and acceptability.

Group Type OTHER

Peptamen 1.3 PHGG

Intervention Type DIETARY_SUPPLEMENT

The amount of tube feed will be assess by the health Care Professional.

Interventions

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Peptamen 1.3 PHGG

The amount of tube feed will be assess by the health Care Professional.

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No