Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
Blends
Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends
2 other identifiers
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2025
CompletedFirst Submitted
Initial submission to the registry
January 6, 2026
CompletedFirst Posted
Study publicly available on registry
January 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 11, 2026
January 14, 2026
January 1, 2026
11 months
January 6, 2026
January 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Measure of Gastrointestinal tolerance
Severity of symptoms such as reflux, vomiting, constipation, diarrhoea as a four-point likert scale (none, mild, moderate, severe).
7 days
Daily record of formula intake.
Measure of formula intake in mL.
28 days
Study Arms (1)
Acceptability and Tolerance Study of bolus tube feed with food blends
OTHERArm one will act as their own controls
Interventions
Dose intake and duration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Queen Medical Hospital Nutrition and Dietetics
Nottingham, NG7 2UH, United Kingdom
Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,
Worcester, WR5 1JR, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Sarah Durnan, PHD, BSc Nutrition Dietetics
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2026
First Posted
January 14, 2026
Study Start
December 10, 2025
Primary Completion (Estimated)
November 10, 2026
Study Completion (Estimated)
November 11, 2026
Last Updated
January 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share