Acceptability & tolerance of 2 paediatric oral nutritional supplements

• Research type

  Research Study

• Full title

  Market research - an acceptability trial for two new paediatric oral nutritional supplements: Nualtra Altrini Shake 44g Nualtra Altrini RTD 125ml

• IRAS ID

  269034

• Contact name

  Katie Stead

• Contact email

  katherine.stead@nhs.net

• Sponsor organisation

  Nualtra Ltd

• Clinicaltrials.gov Identifier

  n/a, n/a

• Duration of Study in the UK

  0 years, 2 months, 1 days

• Research summary

  Disease related malnutrition can be a consequence of many conditions and diseases. It can affect all age groups. Poor appetite and intake of food and liquids as a result of illness or treatment of those illnesses can lead to weight loss or poor growth in peadiatric patients. Oral nutritional supplements are a core part of the treatment and management of disease related malnutrition.

  Altrini shake 44g and Altrini RTD 125ml are 2 new oral nutritional supplements for use in children aged 1 to 14 years. The aim of this trial to ensure they are palatable and tolerated by children within this age range who have or who are at risk of disease related malnutrition.

  This trial seeks to ascertain whether they are palatable for patients, and whether they are tolerated by patients, for example, whether there are any side effects such as vomiting, tummy aches or diarrhoea (these are common side effects in
  already Advisory Committee on Borderline Substances (ACBS) approved products of this nature)

  The outcome of this market research will be included in our application to the ACBS in order to gainapproval for us on prescription. An acceptability trial is obligatory for the ACBS application. The results of this trial will not be published or used in any medical texts.

  Subjects will be asked to take the new product for 7 days. During this time parents/caregivers or the patient (where appropriate) will be asked to complete a daily questionnaire recording information on:

  • Volume of product taken
  • Any gastro-intestinal side-effects

  A questionnaire will also be completed at the beginning and end of the study that will consider perceptions about taste, appearance, smell, presentation and packaging of the product; ease of administration; and any other problems or symptoms.

  The questionnaires should take a maximum of 30 minutes to complete.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  19/NW/0529

• Date of REC Opinion

  6 Sep 2019

• REC opinion

  Further Information Favourable Opinion