Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547346
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-25
Brief Title:
Acceptability and Palatability Study of Paediatric Amino Acid Feed
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 6092013 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None