Status:
COMPLETED
Acceptability and Palatability Study of Paediatric Amino Acid Feed
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Allergy
Eligibility:
All Genders
1-16 years
Phase:
NA
Brief Summary
Product acceptability and palatability data from a minimum of 15 participants are required to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Exe...
Detailed Description
The study product, Alfamino Junior (neutral or vanilla flavour) is a is a food for special medical purposes, as defined by EU Regulation No 609/2013, ACBS approved, prescribable on FP10 (GP10 in Scotl...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Children ≥1 year of age who require an amino acid-based formula (ideally already established on Alfamino or another amino acid formula dependent on feasibility of reaching required numbers or currently on a plant-based milk and need extra nutrition from an amino acid formula) for the dietary management of presumed CMA, or multiple food allergies and other conditions where an amino acid formula is recommended
- All children ≥1 year of age where they are consuming either orally or via a tube 200mls or more of amino acid formula.
- Children with the ability to indicate palatability of the formula (NB there will be simple symbols to help young children and nonverbal children indicate whether the formula is palatable). If an infant is tube fed if they are able to have tastes orally.
- Willingly given, written, informed consent from patient or parent/guardian.
- Exclusion Criteria:
- Inability to comply with the study protocol, in the opinion of the investigator.
- Children less than 1 year of age
- Children with significant renal or hepatic impairment
- Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator e.g. thickener, PPIs etc (must be recorded in patient case record file).
- Participation in another intervention study within 2 weeks of this study.
- Caregiver unable to read and write in English (will need to complete 1 month of forms at home on behalf of participants).
Exclusion
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06547346
Start Date
January 5 2024
End Date
December 16 2024
Last Update
December 27 2024
Active Locations (1)
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1
Paediatric allergy, Leeds Children's Hospital, Clarendon Wing, Leeds General Infirmary, Leeds,
Leeds, United Kingdom, LS1 3EX