Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.

Nestlé

Status: Completed

Conditions: Cerebral Palsy

Treatments: Dietary Supplement: Paediatric Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT03718208

Low calorie 001

Details and patient eligibility

About

This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of a low calorie paediatric peptide based tube feed formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae;

The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

Full description

Patients well established and stable on a standard or peptide enteral tube feed will be changed to a low calorie paediatric formula for a period of seven days. This group will act as their own controls. Each child will receive for a period of seven days the paediatric formula.

The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. A baseline questionnaire will be completed by the dietitian to ensure eligibility of study, current stool patterns or symptoms and weight at the start of the study.

The parents will complete a week intake chart to monitor how much feed has been consumed each day and a tolerance diary to review gastrointestinal symptoms at the start and end of the study.

Enrollment: 15 patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Exclusively tube fed
• Paediatrics aged 1 year above who require a low calorie feed
• Children with Neurological impairment (NI) who require long term tube feeding
• Patients established on a standard or peptide Enteral formula (no gastrointestinal intolerances on a current formula)
• Willingly given, written, informed consent from patient or parent/guardian.
• Willingly given, written assent (if appropriate).

Exclusion criteria

• Inability to comply with the study protocol, in the opinion of the investigator
• Known food allergies to any ingredients (see ingredients list)
• Patients with significant renal or hepatic impairment
• Participation in another interventional study within 2 weeks of this study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Paediatric formula

Experimental group

Description:

Each child will receive for a period of seven days. The formula is a food for special medical purposes for use under medical supervision. The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. One week intake diary, one week tolerance diary, product intake.

Treatment:

Dietary Supplement: Paediatric Formula