Status:
COMPLETED
Acceptability and Tolerance Study of a High Energy Tube Feed with Food Derived Ingredients
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Tolerance
Eligibility:
All Genders
15+ years
Phase:
NA
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 ord...
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-centr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06034951
Start Date
May 24 2023
End Date
December 22 2023
Last Update
September 23 2024
Active Locations (1)
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1
Martha Van Der Linde
Worcester, United Kingdom