Acceptability and Palatability Study of Paediatric Amino Acid Feed

NCT06547346 | Completed

• 1 other identifier: AJ2022
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 Executive (HSE) for Ireland for product registration

Conditions

Allergy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

EXPERIMENTAL

Dietary Supplement: Alfamino Junior

Interventions

Alfamino Junior DIETARY_SUPPLEMENT

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.

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

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

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

Leeds, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: August 9, 2024
• Study Start: January 5, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 16, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

GB (1)