Acceptability and Tolerance Study of a High Energy Tube Feed with Food Derived Ingredients

NCT06034951 | Completed

• 1 other identifier: Compleat002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Tolerance

Outcome Measures

Primary Outcomes (2)

• Daily patient diaries

  Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change

  14 days

• Daily formula intake

  mL per day

  14 days

Study Arms (1)

Patients well established on tube feeds will act as their own control

OTHER

These patients will switch from current to new tube feed to assess acceptability and tolerance

Dietary Supplement: Compleat 1.5 HP

Interventions

Compleat 1.5 HP DIETARY_SUPPLEMENT

Patients well established and stable on an enteral tube feed. This group will act as their own controls and switched to the new tube feed.

Patients well established on tube feeds will act as their own control

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Martha Van Der Linde

Worcester, United Kingdom

Location

Study Officials

• Martha Van Der Linde

  Community Paediatric Dietitian Worcestershire North Nutrition and Dietetic Hastings Way, Worcester. UK

  PRINCIPAL INVESTIGATOR

• Amy Carter

  The Walton Centre NHS Foundation Trust, Liverpool UK

  PRINCIPAL INVESTIGATOR

• Sam Ogundere

  Lewisham and Greenwich NHS Trust London UK

  PRINCIPAL INVESTIGATOR

• Adrian Gilson

  Newham General Hospital London UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 13, 2023
• Study Start: May 24, 2023
• Primary Completion: August 21, 2023
• Study Completion: December 22, 2023
• Last Updated: September 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)