Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465569
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2007-04-23
Brief Title:
A Randomized Double-Blind Placebo-Controlled Study of Oral Milk Immunotherapy for Cows Milk Allergy
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of Oral Milk Immunotherapy for Cows Milk Allergy
Status:
COMPLETED
Status Verified Date:
2017-04
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 determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cows milk in allergic children
Detailed Description:
This is a prospective multi-center clinical trial involving children aged 6 to 21 years with persistent cows milk allergy These children will be recruited from 2 sites Johns Hopkins and Duke University and will undergo initial screening and double-blind placebo-controlled food challenge DBPCFC to confirm threshold dose for reactivity to milk Patients will be treated with milk oral immunotherapy OIT or placebo for 22-30 weeks Those who reach an adequate maintenance dose for OIT will undergo a second DBPCFC Those who develop desensitization will continue with daily milk intake and undergo a third DBPCFC Those in the treatment group who are not desensitized will return to strict avoidance Those in placebo group will be offered to begin treatment or continue with strict milk avoidance Symptom and diet information will be collected initially and at regular intervals Bloodwork skin prick tests SPTs pulmonary function tests PFTs and oral secretion samples will be done initially and at periodic intervals
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