Acceptability and tolerance study of high energy peptide supplement
Research type
Research Study
Full title
Evaluation of the acceptability (including gastrointestinal tolerance, compliance and palatability) of a high energy peptide based paediatric oral nutritional supplement for children over 12 months of age.
IRAS ID
264414
Contact name
Chris Smith
Contact email
Sponsor organisation
Nestle Health Science
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
The purpose of this study is to investigate the acceptability (including gastro intestinal tolerance and compliance) of a high energy peptide based paediatric oral nutritional supplement 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, for the dietary management of participants with medical conditions such as cerebral palsy, cystic fibrosis, short bowel syndrome who require additional calories and protein orally or via a feeding tube.
The study is of relevance to patients, healthcare professionals as it will provide data to be submitted to the Advisory Committee on Borderline Substances (ACBS);
The target patient group will be children over 12 months of age who require a high energy peptide based oral nutritional supplement for increased energy needs and to manage some of the feeding issues either orally or via a feeding tube as a top up feed.
If assent/consent is obtained the participants will have baseline data recorded; height, weight, usual bowel movements. Participants will be provided with a 7 days’ supply of the high energy peptide based paediatric oral nutritional supplement. A dietitian/ paediatrician will determine the formula intake on an individual basis and the formula will be provided in bottles with instructions for the caregiver to prepare.
They will also be asked to complete a short questionnaire daily (taking about 5-10 minutes) in the form of a participant diary recording the following information:
• Gastrointestinal tolerance recorded daily
• Participant compliance with their recommended daily intake of the oral nutritional supplement vs prescribed recorded.
• Palatability recorded on taste, smell, texture and ease of use
Completed questionnaires will be returned to the study team for checking. This can be done by post or the site team calling the parents/caregivers and recording the answers over the phone. Other option is if parents/caregivers prefer they can attend the clinic a week later to hand in the questionnaires to discuss with site team.REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/0802
Date of REC Opinion
15 May 2019
REC opinion
Favourable Opinion