Acceptability and Tolerance Study of Peptide Feed with Fibre

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.

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.

Study Overview

• Status: Completed
• Conditions: Dietary Exposure
• Intervention / Treatment: Dietary supplement: Peptamen 1.3 PHGG

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom
    • Nutrition and Dietetics
  • Newcastle, United Kingdom
    • Nutrition and Dietetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Dietary supplement: Peptamen 1.3 PHGG; The amount of tube feed will be assess by the health Care Professional.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Stephanie Wakefield, Newcastle Upon Tyne Hospital Trust; Principal Investigator: Nirouz Zarroug, Liverpool university Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Actual): September 3, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Peptide 003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will upload the data as it becomes available
• IPD Sharing Time Frame: End of study
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No