Acceptability and Tolerance Study of Peptide Feed With Fibre

Not Applicable

Recruiting

• Conditions: Dietary Exposure
• Interventions: Dietary Supplement: Peptamen 1.3 PHGG

• Registration Number: NCT06102135
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-08-22
• Study Start: 2023-09-05
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Primary Completion: 2024-09-21
• Study Completion: 2024-09-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients well established on tube feeds will act as their own control	Peptamen 1.3 PHGG	Patients in the control group will switch from current feed to new tube feed to assess tolerance and acceptability.

Primary Outcome Measures

Name	Time	Method
Assess tolerance via patient diaries	14 days	Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating
Daily formula intake	14 days	mL

Trial Locations

Locations (1)

Nutrition and Dietetics; 🇬🇧 Newcastle, United Kingdom