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

Tolerance Clinical Trial

Official title:

Acceptability (Including Gastrointestinal Tolerance and Compliance) of a High Energy, Adult Enteral Formula With Food-derived Ingredients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06034951
• Other study ID #: Compleat002
• Status: Completed
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: December 22, 2023

Study information

• Verified date: April 2024
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 22, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tolerance

Intervention

Dietary Supplement:
• Compleat 1.5 HP
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.

Locations

Country	Name	City	State
United Kingdom	Martha Van Der Linde	Worcester

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	Daily patient diaries	Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change	14 days
Primary	Daily formula intake	mL per day	14 days