Clinical Trials in the UK / NCT07341464
Recruiting
Not applicable
Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
NCT07341464 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Cerebral Palsy (CP)Oncology
Investigational drug(s) / intervention(s)
Tube feed
Tube feed: Dose intake and duration.
Study 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.
Eligibility
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 |
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Official registry record
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.
View NCT07341464 on ClinicalTrials.gov ↗ ← All trials in the UK