Acceptability and tolerance study of Alfamino with HMOs

• Research type

  Research Study

• Full title

  To evaluate the acceptability (including gastro intestinal tolerance and compliance) of a hypoallergenic amino acid infant formula with HMOs for the dietary management of cows’ milk allergy in infants less than 12 months of age.

• IRAS ID

  263661

• Contact name

  Donald Hodge

• Contact email

  donaldhodge@nhs.net

• Sponsor organisation

  Nestle Health Science

• Clinicaltrials.gov Identifier

  NCT04575298

• Duration of Study in the UK

  2 years, 8 months, 29 days

• Research summary

  The purpose of this study is to investigate the acceptability and to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of Alfamino with added HMO and reduced protein. Alfamino an extensively hydrolysed formula for complete nutritional support from birth or supplementary feeding from 6 months and up to 12 months of age for the dietary management of cows’ milk allergy.
  It is anticipated the study will open in up to 5 sites in the UK to recruit the required number of participants in the required time-frame.
  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
  If assent/consent is obtained the participants will have baseline data recorded; height, weight, usual bowel movements. The participants will change to Alfamino for 7 days (the dosage will be determined by the dietitian to provide equivalent to the usual feed). Participants will be provided with a 7 days’ supply of Alfamino with HMOs and reduced protein. 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
  • Compliance via daily assessment of actual vs recommended product intake

  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.

  The study team to then return completed questionnaires to the CRO (Ixia Clinical (CRO) Ltd

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  19/LO/0995

• Date of REC Opinion

  18 Jun 2019

• REC opinion

  Favourable Opinion