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.
Eligibility
Sex
ALL
Min age
1 Year
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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.
Trial sites (2)
Facility
City
Region
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
More Société des Produits Nestlé (SPN) trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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