Acceptability and Palatability Study of Paediatric Amino Acid Feed

Nestlé

Status

Completed

Conditions

Allergy

Treatments

Dietary Supplement: Alfamino Junior

Study type

Interventional

Funder types

Industry

Identifiers

NCT06547346

AJ2022

Details and patient eligibility

About

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 Executive (HSE) for Ireland for product registration

Full 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 Scotland).

Alfamino Junior (neutral or vanilla flavour) is is for complete nutritional support of children ≥1 year with cows' milk allergy, multiple food allergies and other conditions where an amino acid formula is recommended.

This is an open label nonrandomised acceptability, palatability and compliance study to evaluate the tolerance of the study formulas in 15 children.

Palatability is recorded over a 7day study period, acceptability is recorded days 1-7 and days 22-28 of the study period, with patient compliance recorded over the full 28 day study period

Enrollment

15 patients

Sex

All

Ages

1 to 16 years old

Volunteers

No Healthy Volunteers

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).