Acceptability and Tolerance Study of a Plant-based Tube Feed

Last updated: September 19, 2024
Sponsor: Société des Produits Nestlé (SPN)
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Compleat plant protein tube feed

Clinical Study ID

NCT06209593
PB 001
  • Ages 16-80
  • All Genders

Study Summary

This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 7-day period with a plant based tube feed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 16 years and over and adults requiring a plant- based enteral tube feed (taking 50% or more of energy needs from their feeding tube) as part of theirdietary management for disease related malnutrition

  • Patients well-established and stable on current polymeric enteral tube feed.

  • Willingly given, written, informed consent from patient

Exclusion

Exclusion Criteria:

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

  • Under 16 years of age

  • Patients on total parenteral nutrition

  • Known food allergies to any ingredients including patients who have an allergy tomilk protein e.g IgE and non- mediated as product contains traces of milk andallergy to peanuts due to the pea protein

  • Patients with significant renal or hepatic impairment

  • Participation in another interventional study within 2 weeks of this study.

  • Patients with known or suspected ileus or mechanical bowel obstruction

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Compleat plant protein tube feed
Phase:
Study Start date:
January 05, 2024
Estimated Completion Date:
September 03, 2024

Study Description

Enterally fed adults who are assessed by the Health Care Professional/dietitian as requiring an adult plant- based high-energy, enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the UK Advisory Committee on Borderline Substances (ACBS) for product registration

Connect with a study center

  • Nu

    London,
    United Kingdom

    Site Not Available

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