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NCT Number: NCT07341464

Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends

This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants.

The enteral bolus formula is for the dietary management of patients with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, and disease related malnutrition.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Neoplasms Nervous System Diseases Oncology

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Medical Hospital Nutrition and Dietetics, Nottingham, United Kingdom

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About this study

The study will collect data in 50 children and adults over a period of 28 days. Gastrointestinal tolerance will be collected over 7 days and formula intake will be over 28 days. A patient satisfaction questionnaire will be completed at the end of the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients from 1 -15 years for children and 15 years and above for adults of requiring 1 or more bolus tube feed alongside their usual tube feed or home-made blended diet as part of their dietary management for disease related malnutrition.
  • Patients well-established and stable on current enteral tube feed or home-made blended diet.
  • Gastrostomy fed only.
  • Willingly given, written, informed consent from patient/caregiver

Exclusion criteria

  • Inability to comply with the study protocol, in the opinion of the investigator.
  • Under 1 years of age
  • Patients who have a nasogastric and jejunal feeding tubes
  • Patients on total parenteral nutrition
  • Known food allergies to any ingredients listed in appendix 1.
  • Patients with significant renal or hepatic impairment
  • Participation in another interventional study within 2 weeks of this study.
  • Patients with known or suspected ileus or mechanical bowel obstruction

Treatment and study plan

Tube Feed

Dietary Supplement

Dose intake and duration.

Primary outcomes

  1. Measure of Gastrointestinal tolerance

    Time frame: 7 days

    Severity of symptoms such as reflux, vomiting, constipation, diarrhoea as a four-point likert scale (none, mild, moderate, severe).

  2. Daily record of formula intake.

    Time frame: 28 days

    Measure of formula intake in mL.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Durnan, PHD, BSc Nutrition Dietetics

CONTACT

Sharan Saduera, BSc (Hons) Dietetics

CONTACT

[email protected]

+447557170649

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends

Acronym: Blends

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

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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