Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329784
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2006-05-23
Brief Title:
Promoting Tolerance to Peanut in High-Risk Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Induction of Tolerance Through Early Introduction of Peanut in High-Risk Children ITN032AD
Status:
COMPLETED
Status Verified Date:
2019-04
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:
LEAP
Brief Summary:
This study will evaluate whether early exposure to peanuts promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema
This study has been continued into the ITN049AD LEAP-On Study NCT01366846
This study has been continued into the ITN049AD LEAP-On Study NCT01366846
Detailed Description:
Allergic reactions to peanuts are potentially life-threatening and in some children can result from ingestion of only trace quantities of peanuts At highest risk are children with eczema or who are allergic to eggs these children have a 20 chance of developing peanut allergy by the age of five The majority of children allergic to peanuts have their first reaction between the ages of 14 and 24 months often at the time of their first exposure to peanut Currently there is no cure for peanut allergy
Peanut allergy has become an increasingly common problem in early childhood in the United States and the United Kingdom Despite current public health guidelines in both countries recommending the avoidance of peanut consumption in the first years of life the proportion of children with peanut allergy doubled in these countries over the period from 1998 to 2003 In contrast peanuts are commonly consumed by infants in relatively high amounts in Africa Southeast Asia and Israel yet the rate of peanut allergy is quite low and does not appear to be increasing Peanut consumption by infants in these parts of the world may actually protect children from developing peanut allergy by promoting oral tolerance to peanuts
Participants in this study will be randomly assigned to either follow a peanut consumption regimen or a strict peanut avoidance regimen Those assigned to the peanut consumption group will be asked to consume an age-appropriate snack three times a week for the duration of the study and will be monitored closely during their first introduction to peanut
Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for the first three years of life A physical exam allergy testing and other immune system tests requiring blood collection will occur at Years 1 3 and 5 following study entry During the study parents will maintain regular contact with study dietitians
Peanut allergy has become an increasingly common problem in early childhood in the United States and the United Kingdom Despite current public health guidelines in both countries recommending the avoidance of peanut consumption in the first years of life the proportion of children with peanut allergy doubled in these countries over the period from 1998 to 2003 In contrast peanuts are commonly consumed by infants in relatively high amounts in Africa Southeast Asia and Israel yet the rate of peanut allergy is quite low and does not appear to be increasing Peanut consumption by infants in these parts of the world may actually protect children from developing peanut allergy by promoting oral tolerance to peanuts
Participants in this study will be randomly assigned to either follow a peanut consumption regimen or a strict peanut avoidance regimen Those assigned to the peanut consumption group will be asked to consume an age-appropriate snack three times a week for the duration of the study and will be monitored closely during their first introduction to peanut
Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for the first three years of life A physical exam allergy testing and other immune system tests requiring blood collection will occur at Years 1 3 and 5 following study entry During the study parents will maintain regular contact with study dietitians
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