Clinical trial · Interventional
Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebral Palsy (CP) | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tube feed | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Acceptability and Tolerance Study of bolus tube feed with food blends
- description
- Arm one will act as their own controls
- interventionNames
- Dietary Supplement: Tube feed
Primary outcomes (2)
- measure
- Measure of Gastrointestinal tolerance
- timeFrame
- 7 days
- description
- Severity of symptoms such as reflux, vomiting, constipation, diarrhoea as a four-point likert scale (none, mild, moderate, severe).
- measure
- Daily record of formula intake.
- timeFrame
- 28 days
- description
- Measure of formula intake in mL.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
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
References
Publications (0)
Data not yet available