Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2026-11-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Palsy (CP) Oncology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Acceptability and Tolerance Study of bolus tube feed with food blends

Arm one will act as their own controls

Group Type OTHER

Tube feed

Intervention Type DIETARY_SUPPLEMENT

Dose intake and duration.

Interventions

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Tube feed

Dose intake and duration.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No