Acceptability and Tolerance Study of Peptide Feed with Fibre

Nestlé

Status: Completed

Conditions: Dietary Exposure

Treatments: Dietary Supplement: Peptamen 1.3 PHGG

Study type: Interventional

Funder types: Industry

Identifiers

NCT06102135

Peptide 003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

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

Other group

Description:

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

Treatment:

Dietary Supplement: Peptamen 1.3 PHGG