RecruitingNot ApplicableNCT07341464

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


Sponsor

Société des Produits Nestlé (SPN)

Enrollment

50 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 Year

Inclusion Criteria4

  • 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 Criteria8

  • 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

Interventions

DIETARY_SUPPLEMENTTube feed

Dose intake and duration.


Locations(2)

Queen Medical Hospital Nutrition and Dietetics

Nottingham, United Kingdom

Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,

Worcester, United Kingdom

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NCT07341464


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