Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Measure of Gastrointestinal tolerance
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Outcomes
Primary Outcomes
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).
Daily record of formula intake.
Time Frame: 28 days
Measure of formula intake in mL.
Secondary Outcomes
No secondary outcomes reported