Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends

Nestlé

Status: Enrolling

Conditions: Oncology; Cerebral Palsy (CP)

Treatments: Dietary Supplement: Tube feed

Study type: Interventional

Funder types: Industry

Identifiers

NCT07341464

IRAS ID 341165 (Other Identifier)

BTB 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Acceptability and Tolerance Study of bolus tube feed with food blends

Other group

Description:

Arm one will act as their own controls

Treatment:

Dietary Supplement: Tube feed