Acceptability and tolerance study of Isosource Junior Mix
Research type
Research Study
Full title
To 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.
IRAS ID
245055
Contact name
Clare Thornton- Wood
Contact email
Sponsor organisation
Nestle Health Science
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
The purpose of this study is to investigate the acceptability (including gastro intestinal tolerance and compliance) of a paediatric tube-feed formula containing ingredients derived from real food for children over 12 months of age.This is an acceptability study to evaluate the gastrointestinal tolerance and compliance in 15 children over a seven-day period, of Isosource Junior Mix 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 study will be conducted in schools for children with complex needs and a dietetic community centre.
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 age 1 year - 18 years established on a tube feed.
Recruitment will be undertaken by the chief investigator approaching residential schools and a dietetic community centre to identify potential participants; this will be followed by discussions with the children and 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 Isosource Junior Mix 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
London - Hampstead Research Ethics Committee
REC reference
18/LO/0546
Date of REC Opinion
4 Jun 2018
REC opinion
Further Information Favourable Opinion