Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tube feed.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy (CP), Oncology. Basic parameters: from 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends
Overview
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.
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.
Interventions
- Dietary supplement Tube feed
Dose intake and duration.
Primary outcome measures
- Measure of Gastrointestinal tolerance [Time frame: 7 days]
- Daily record of formula intake. [Time frame: 28 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United Kingdom · 2 centers
- Queen Medical Hospital Nutrition and Dietetics — Nottingham
- Dietetic Team 1st floor Kings Court 1, Charles Hastings Way, — Worcester
Identifiers
NCT: NCT07341464 · BTB 001 · IRAS ID 341165