Acceptability and Palatability Study of Paediatric Amino Acid Feed

Last updated: December 26, 2024
Sponsor: Société des Produits Nestlé (SPN)
Overall Status: Completed

Phase

N/A

Condition

Allergy

Allergy (Pediatric)

Allergies & Asthma

Treatment

Alfamino Junior

Clinical Study ID

NCT06547346
AJ2022
  • Ages 1-16
  • All Genders

Study 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 Executive (HSE) for Ireland for product registration

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Children ≥1 year of age who require an amino acid-based formula (ideally alreadyestablished on Alfamino or another amino acid formula dependent on feasibility ofreaching required numbers or currently on a plant-based milk and need extranutrition from an amino acid formula) for the dietary management of presumed CMA, ormultiple food allergies and other conditions where an amino acid formula isrecommended

  • 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 besimple symbols to help young children and nonverbal children indicate whether theformula is palatable). If an infant is tube fed if they are able to have tastesorally.

  • Willingly given, written, informed consent from patient or parent/guardian.

Exclusion

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 supplementsduring the study period, unless clinically indicated and prescribed by theinvestigator e.g. thickener, PPIs etc (must be recorded in patient case recordfile).

  • 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 offorms at home on behalf of participants).

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Alfamino Junior
Phase:
Study Start date:
January 05, 2024
Estimated Completion Date:
December 16, 2024

Study 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

Connect with a study center

  • Paediatric allergy, Leeds Children's Hospital, Clarendon Wing, Leeds General Infirmary, Leeds,

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

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