Acceptability and tolerance study of a low calorie peptide feed
Research type
Research Study
Full 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.
IRAS ID
247770
Contact name
Hayley Kuter
Contact email
Sponsor organisation
Nestle Health Science
Duration of Study in the UK
0 years, 3 months, 7 days
Research summary
The purpose of this study is to investigate the acceptability (including gastro intestinal tolerance and compliance) of a low calorie paediatric peptide based tube feed children over 1 year of age. This is an acceptability study to evaluate the gastrointestinal tolerance and compliance in 15 children who have neurological impairment over a seven-day period for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistula. The study will be conducted in community dietetic centres and outpatient settings.
The study is of relevance to patients, healthcare professionals and the general public as it will provide data to be submitted to the Advisory Committee on Borderline Substances (ACBS); the ACBS is the governing body that makes the decision whether the product can be prescribed for patient use at the expense of the NHS.
Participants will be children over the age of 1 year and established on a tube feed.
Recruitment will be undertaken by the chief investigator approaching at dietetic community centres, outpatient clinics to identify potential participants; this will be followed by discussions with their parents/guardians to find out if they would like to be included in the study.
If assent/consent is obtained the participants will have baseline data recorded; height, weight, usual bowel movements and a 3 day dietary history (only if also consuming food orally). The participants will change to a low calorie peptide based feed for 7 days (the dosage will be determined by the dietitian to provide equivalent to the usual feed). Data on tolerance, dosage, bowel movements and any gastrointestinal symptoms will be recorded each day. At the end of the study the patients will have their weight checked again.
REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0412
Date of REC Opinion
10 Jul 2018
REC opinion
Further Information Favourable Opinion