Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481280
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-20
Brief Title:
Evaluation of Tolerance Efficacy and Safety of an Hydrolyzed Formula in Infants With IgENon-IgE Mediated CMA
Sponsor:
United Pharmaceuticals
Organization:
United Pharmaceuticals
Study Overview
Official Title:
Cows Milk Allergy CMA Evaluation of Tolerance Efficacy and Safety of a Thickened Extensively Hydrolyzed Formula in Infants With IgE and Non-IgE Mediated CMA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
MERLIN
Brief Summary:
The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy CMA whatever the type of CMA meaning in both IgE-mediated and non-IgE-mediated CMA patients
This will be tested through a double-blind placebo controlled food challenge DBPCFC taking place over 2 or 3 separate days in hospital
If the child tolerates the tested formula during the DBPCFC he will be fed with the test formula during the second study phase There will be monthly visit and parents will be asked to fill in diaries
This will be tested through a double-blind placebo controlled food challenge DBPCFC taking place over 2 or 3 separate days in hospital
If the child tolerates the tested formula during the DBPCFC he will be fed with the test formula during the second study phase There will be monthly visit and parents will be asked to fill in diaries
Detailed Description:
Briefly on two separate days the placebo formula and the TEHCF will be introduced at increasing doses under medical supervision and appearance of allergic symptoms will be witnessed and recorded if any The week after and more particularly the 72 hours after each food challenge day childs parents will be instructed to report to the investigator any delayed reaction that may occur In case the TEHCF induces an allergic reaction the childs participation will be ended Otherwise the child will enter the second study part lasting 4 months and during which the usual formula taken by the child will be totally replaced by the TEHCF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None