Acceptability and Palatability Study of Paediatric Amino Acid Feed

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.

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

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Dietary supplement: Alfamino Junior

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 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

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS1 3EX
    • Paediatric allergy, Leeds Children's Hospital, Clarendon Wing, Leeds General Infirmary, Leeds,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients well established on tube feeds will act as their own control

Dietary supplement: Alfamino Junior; To recruit 15 children and evaluate the acceptability (including gastrointestinal tolerance), palatability and compliance of a hypoallergenic amino acid powdered formula (neutral and vanilla flavours) with HMO's for the dietary management of presumed cows' milk allergy, multiple food protein allergies and other conditions where an amino acid formula is recommended in children ≥1 year of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of children reporting gastrointestinal tolerance using an online questionnaire.	Number of patients reporting diarrhoea and / or constipation, Bloating and / or distension, Nausea and / or vomiting, Burping / flatulence / regurgitation, Abdominal discomfort/ pain, measured as symptoms and graded as none, mild moderate or severe	7 days
Palatability, indicated via symbols of how much the product is liked using online questionnaire.	Number of children who like the appearance, taste, smell graded as as 5 likert scale of an online questionnaire from really liked to really did not like using happy to sad images to correctly identify outcome.	7 days
Participant compliance	How many feeds and volume prescribed each day, How many feeds and volume taken	7 days

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: AJ2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No