Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 12:42 AM
Study NCT ID:
NCT01109966
Status:
TERMINATED
Last Update Posted:
2017-05-08
First Post:
2010-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy
Sponsor:
Nutricia Research
Organization:
Study Overview
Official Title:
A Prospective, Double Blind Randomised Controlled Trial to Evaluate the Immunological Benefits and Clinical Effects of an Elimination Diet Using an Amino Acid Based Formula (AAF)
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.
Detailed Description:
Infants with CMA cannot tolerate proteins contained in milk, although they are able to tolerate amino acids which are the 'building blocks' of proteins. Unlike standard infant formulas which are made from milk proteins, amino acid formulas (AAF) are made from nonallergenic aminoacids plus all the other nutrients required to support growth and development.
Study Oversight
Has Oversight DMC:
False
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?: