Acceptability and tolerance study of Resource Thicken up Junior
Research type
Research Study
Full title
Evaluation of the acceptability (including gastrointestinal tolerance, compliance) of a thickener for those aged 6 months and above.
IRAS ID
280585
Contact name
Analou Sugar
Contact email
Sponsor organisation
Nestle Health Sciences
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 6 days
Research summary
The purpose of this study is to investigate the acceptability the gastrointestinal tolerance and compliance of an infant thickener for those aged 6 months and above
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance in 15 children over a seven-day period, for children with reflux, GORD and dysphagia requiring a thickener or on a current infant thickener.
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); Each infant will be switch over to receive for a period of 7 days (new infant thickener) The Speech and Language therapist (SLT) will determine the thickener amount on an individual basis and the thickener will be provided in tins with instructions for the caregiver to prepare.
If 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 thickener. A dietitian/ speech language therapist will determine the formula intake on an individual basis and the formula will be provided in bottles and a mixing guide 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 tolerance 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.
Also they have a 7 day intake diary on suggested volumes vs actual taken volumes.
Completed questionnaires will be returned to the study team for checking. The site will be provided with self addressed envelopes to give to the parents.
The site will then send onto the CRO contact and sponsor.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0102
Date of REC Opinion
13 May 2020
REC opinion
Further Information Favourable Opinion