Acceptability and Tolerance Study of a High Energy Tube Feed With Food Derived Ingredients

Not Applicable

Completed

• Conditions: Tolerance
• Interventions: Dietary Supplement: Compleat 1.5 HP

• Registration Number: NCT06034951
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. 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 a high energy, adult enteral formula with food-derived ingredients.This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with the new tube feed.

Participants or their caregivers will be provided with 14-day supply of the new tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following:

* Gastrointestinal tolerance

* Compliance with prescribed feed volume

Study Timeline

• Study Start: 2023-05-24
• Primary Completion: 2023-08-21
• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-13
• Study Completion: 2023-12-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Patients requiring an enteral tube feed (taking > 60% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition

  • Children 15 years and over
  • Adults and children requiring an adult high-energy and fibre-containing formula, as assessed by the dietitian.
  • Patients well-established and stable on enteral feeding.
  • Willingly given, written, informed consent from patient or consultee
  • Willingly given, written assent (if appropriate).

Exclusion Criteria

• Inability to comply with the study protocol, in the opinion of the investigator

  • Children under 15 years of age
  • 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	Compleat 1.5 HP	These patients will switch from current to new tube feed to assess acceptability and tolerance

Primary Outcome Measures

Name	Time	Method
Daily formula intake	14 days	mL per day
Daily patient diaries	14 days	Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change

Trial Locations

Locations (1)

Martha Van Der Linde; 🇬🇧 Worcester, United Kingdom