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Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends

Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends

Recruiting
1 years and older
All
Phase N/A

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Overview

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.

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 questionnaire will be completed at the end of the study.

Eligibility

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

Study details
    Cerebral Palsy (CP)
    Oncology

NCT07341464

Société des Produits Nestlé (SPN)

1 February 2026

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