Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends

NCT07341464 — Not applicable, Recruiting, 50 participants, Société des Produits Nestlé (SPN)

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

Registry	NCT07341464, acronym Blends
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, health services research
Enrollment	50 (Estimated)
Sponsor	Société des Produits Nestlé (SPN) (Industry)
Conditions	Cerebral Palsy (CP), Oncology
Interventions	Tube feed (Dietary supplement)
Dates	start 2025-12-10, primary completion 2026-11-10 (estimated), completion 2026-11-11 (estimated), first posted 2026-01-14, last updated 2026-01-14
Locations	2 sites in United Kingdom

-Summary

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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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Acceptability and Tolerance Study of bolus tube feed with food blends	Other	Dietary Supplement: Tube feed	Arm one will act as their own controls

Tube feed (Dietary supplement): Dose intake and duration.

+Outcome measures

Primary outcomes

Measure of Gastrointestinal tolerance [7 days]: Severity of symptoms such as reflux, vomiting, constipation, diarrhoea as a four-point likert scale (none, mild, moderate, severe).
Daily record of formula intake. [28 days]: Measure of formula intake in mL.

+Eligibility

Sex: All, ages: 1 Year to any

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

+Locations (2)

Facility	City	Country	Status
Queen Medical Hospital Nutrition and Dietetics	Nottingham	United Kingdom	Not yet recruiting
Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,	Worcester	United Kingdom	Recruiting