Clinical trial NCT06034951: Acceptability and Tolerance Study of a High Energy Tube Feed with Food Derived Ingredients
Official title: Acceptability (including Gastrointestinal Tolerance and Compliance) of a High Energy, Adult Enteral Formula with Food-derived Ingredients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tolerance
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 16
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Daily patient diaries
timeFrame: 14 days
measure: Daily formula intake
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United Kingdom
facility: Martha Van Der Linde
Study officials:
affiliation: Community Paediatric Dietitian Worcestershire North Nutrition and Dietetic Hastings Way, Worcester. UK
name: Martha Van Der Linde
role: PRINCIPAL_INVESTIGATOR
affiliation: The Walton Centre NHS Foundation Trust, Liverpool UK
name: Amy Carter
role: PRINCIPAL_INVESTIGATOR
affiliation: Lewisham and Greenwich NHS Trust London UK
name: Sam Ogundere
role: PRINCIPAL_INVESTIGATOR
affiliation: Newham General Hospital London UK
name: Adrian Gilson
role: PRINCIPAL_INVESTIGATOR
References: