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Completed

NCT Number: NCT06034951

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

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.

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Key information

Conditions

Tolerance

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martha Van Der Linde

Worcester, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Daily patient diaries

    Time frame: 14 days

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

  2. Daily formula intake

    Time frame: 14 days

    mL per day

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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