Allergy
Conditions
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
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
Interventions
DIETARY_SUPPLEMENTAlfamino 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.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of children reporting gastrointestinal tolerance using an online questionnaire. | 7 days | 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 |
| Palatability, indicated via symbols of how much the product is liked using online questionnaire. | 7 days | 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. |
| Participant compliance | 7 days | How many feeds and volume prescribed each day, How many feeds and volume taken |
Countries
United Kingdom
Outcome results
None listed