Acceptability and Tolerance Study of a Plant-based Tube Feed (NCT06209593) | Clinical Trial Compass
CompletedNot Applicable
Acceptability and Tolerance Study of a Plant-based Tube Feed
United Kingdom15 participantsStarted 2024-01-05
Plain-language 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.
Who can participate
Age range16 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Baseline assessment and daily recording during intervention up to day 7 measuring Gastrointestinal tolerance