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

Société des Produits Nestlé (SPN)15 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

Paediatric FormulaDIETARY_SUPPLEMENT

Children will switch over to the low calorie paediatric feed. Intake diaries and tolerance diaries will be completed for one week.

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 Years

Medical Language ↔ Plain English

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.

Locations (3)

Waldron Health Centre

Amersham, United Kingdom

Alexandra Children's Hospital

Brighton, United Kingdom

Gorton Clinic

Manchester, United Kingdom

Outcomes

Primary Outcomes

Gastrointestinal tolerance

Incidence of gastrointestinal adverse effects \[ Time Frame: day 7 from baseline \]. Tolerance will be evaluated on the basis of the number of gastrointestinal events including diarrhea, constipation, bloating, distension, nausea, vomiting, burping, flatulence and regurgitation and abdominal discomfort or pain reported for subjects during their participation in the study. nausea, vomiting. burping, flatulence and regurgitation and abdominal discomfort or pain

Time frame: Day 7 from baseline

Participant compliance

Volume of test product prescribed versus actually taken

Time frame: Day 7 from baseline

Secondary Outcomes

Body weight

Weight will be measured in Kg

Time frame: Day 7 from baseline

Data from ClinicalTrials.gov

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