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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Page 1 of 1 (2 locations)

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

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