Child Nutrition Disorders Clinical Trial
Official title:
Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Paediatric Tube-feed Formula Ingredients Derived From Real Food for Children Over 12 Months of Age
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of pediatric 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; feeding intolerances, developmental disabilities, disease related malnutrition 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 enteral tube feed will be changed to a
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, a nutritionally
complete standard enteral tube feed.
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, current
oral intake 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.
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