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NCT06209593 Clinical Trial

Acceptability and Tolerance Study of a Plant-based Tube Feed

Nutrition Disorders Clinical Trial

Official title:
Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Plant Based High Energy Adult Enteral Formula

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06209593
Other study ID # PB 001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 5, 2024
Est. completion date June 3, 2024

Study information
Verified date January 2024
Source Société des Produits Nestlé (SPN)
Contact James Evans
Phone 0203 447 9289
Email j.evans28@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date June 3, 2024
Est. primary completion date May 3, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 80 Years
Eligibility 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 their dietary management for disease related malnutrition - Patients well-established and stable on current polymeric enteral tube feed. - Willingly given, written, informed consent from patient 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 to milk protein e.g IgE and non- mediated as product contains traces of milk and allergy 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Compleat plant protein tube feed
Patients on a tube feed will act as their own control and switch to new tube feed.

Locations
Country Name City State
United Kingdom Nu London

Sponsors (1)
Lead Sponsor Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Baseline assessment and daily recording during intervention up to day 7 measuring Gastrointestinal tolerance Diarrhoea, constipation, reflux, vomiting, wind, boating 7 days
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