Acceptability and palatability study of Alfamino Junior

• Research type

  Research Study

• Full title

  To evaluate the acceptability and palatability of a hypoallergenic nutritionally complete powdered amino acid formula with HMO (Human Milk Oligosaccharides) for the dietary management of cows’ milk allergy (CMA) and multiple food protein allergies (MFPA) in children over ≥1 year.

• IRAS ID

  311790

• Contact name

  Donald Hodge

• Contact email

  donaldhodge@nhs.net

• Sponsor organisation

  Nestle Health Science

• Duration of Study in the UK

  0 years, 7 months, 29 days

• Research summary

  The purpose of this study is to investigate the acceptability and to evaluate the gastrointestinal tolerance, palatability, and compliance via parent/carer electronic recording over 28-days, of Alfamino Junior. Alfamino Junior is a hypoallergenic amino acid powdered formula for the dietary management of cow’s milk allergy, multiple food protein allergies and other conditions where an amino acid formula is recommended in children ≥1 year of age.

  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. Also to the HSE for Ireland to be reimbursed under the GMS and community drug schemes.

  If parent/caregiver consent is obtained the participants will have baseline data recorded; height, weight, usual bowel movements. The participants will change to Alfamino Junior from their current amino acid formula to Alfamino Junior for 28 days with a 7days recording of palatability, 14 days recording of GI tolerance (first 7days and last 7 days of study) and 28 day of compliance to the product.
  The parents/caregiver will also be asked to complete a short questionnaire daily (taking about 5-10 minutes) via a link for Microsoft Forms on their computer, phone or tablet. The form will ask for the following information:
  • Gastrointestinal tolerance and palatability.
  • Compliance via daily assessment of actual vs recommended product intake

  Once the data has been completed and submitted daily on Microsoft forms it is submitted direct to the sponsor. There will be no patient identifiable data asked. The parents will be given a patient number by the dietician.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  22/NE/0065

• Date of REC Opinion

  30 May 2022

• REC opinion

  Further Information Favourable Opinion