Status:
RECRUITING
Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Cerebral Palsy (CP)
Oncology
Eligibility:
All Genders
1+ years
Phase:
NA
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 ...
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...
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
Key Trial Info
Start Date :
December 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 11 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07341464
Start Date
December 10 2025
End Date
November 11 2026
Last Update
January 14 2026
Active Locations (2)
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1
Queen Medical Hospital Nutrition and Dietetics
Nottingham, United Kingdom, NG7 2UH
2
Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,
Worcester, United Kingdom, WR5 1JR