Acceptability and Palatability Study of Paediatric Amino Acid Feed (NCT06547346) | Clinical Trial Compass
CompletedNot Applicable
Acceptability and Palatability Study of Paediatric Amino Acid Feed
United Kingdom15 participantsStarted 2024-01-05
Plain-language 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
Who can participate
Age range1 Year – 16 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ho…
What they're measuring
1
Number of children reporting gastrointestinal tolerance using an online questionnaire.
Timeframe: 7 days
2
Palatability, indicated via symbols of how much the product is liked using online questionnaire.