Cerebral Palsy Clinical Trial
Official title:
To Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Low Calorie Peptide Based Paediatric Tube-feed Formula; for Children Greater Than 1 Year of Age.
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.
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