Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
640 participants
INTERVENTIONAL
2006-12-31
2014-05-31
Brief Summary
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This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peanut Consumption Group
Participants on this arm will consume peanut protein.
Peanut Consumption Group
Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
Peanut Avoidance Group
Participants on this arm will avoid peanut as per United Kingdom (UK) public health recommendations.
No interventions assigned to this group
Interventions
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Peanut Consumption Group
Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Allergy to eggs and/or severe eczema
* Informed consent obtained from parent or guardian.
Exclusion Criteria
* Positive skin prick test for peanut allergen with a wheel diameter greater than 4 mm in the presence of a negative saline control
* Previous or current consumption of peanut protein that exceeds 0.2 g of peanut protein on at least one occasion or 0.5 g over a single week
* Investigator-suspected allergy to peanut protein
* Investigator-suspected allergy to peanut protein in care provider or current household member.
* Diagnosis of persistent asthma
* ALT (SGPT) or bilirubin greater than 2 times the upper limit of age-related normal value
* BUN or creatinine greater than 1.25 times the upper limit of age-related normal value
* Platelet count less than 100,000/mL, hemoglobin less than 9 g/dL, or investigator-suspected immunocompromise
* Unwillingness or inability to comply with study requirements and procedures
4 Months
10 Months
ALL
No
Sponsors
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Immune Tolerance Network (ITN)
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Gideon Lack, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College, St. Mary's Hospital
Locations
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Evelina Children's Hospital, Guy's & St Thomas' NHS Foundation Trust
London, England, United Kingdom
Countries
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References
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Palmer K, Burks W. Current developments in peanut allergy. Curr Opin Allergy Clin Immunol. 2006 Jun;6(3):202-6. doi: 10.1097/01.all.0000225161.60274.31.
Santos AF, Du Toit G, Lack G. Is the use of epinephrine a good marker of severity of allergic reactions during oral food challenges? J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):429-30. doi: 10.1016/j.jaip.2014.12.009. No abstract available.
Du Toit G, Sayre PH, Roberts G, Sever ML, Lawson K, Bahnson HT, Brough HA, Santos AF, Harris KM, Radulovic S, Basting M, Turcanu V, Plaut M, Lack G; Immune Tolerance Network LEAP-On Study Team. Effect of Avoidance on Peanut Allergy after Early Peanut Consumption. N Engl J Med. 2016 Apr 14;374(15):1435-43. doi: 10.1056/NEJMoa1514209. Epub 2016 Mar 4.
Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF, Brough HA, Phippard D, Basting M, Feeney M, Turcanu V, Sever ML, Gomez Lorenzo M, Plaut M, Lack G; LEAP Study Team. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015 Feb 26;372(9):803-13. doi: 10.1056/NEJMoa1414850. Epub 2015 Feb 23.
Gruchalla RS, Sampson HA. Preventing peanut allergy through early consumption--ready for prime time? N Engl J Med. 2015 Feb 26;372(9):875-7. doi: 10.1056/NEJMe1500186. Epub 2015 Feb 23. No abstract available.
Du Toit G, Roberts G, Sayre PH, Plaut M, Bahnson HT, Mitchell H, Radulovic S, Chan S, Fox A, Turcanu V, Lack G; Learning Early About Peanut Allergy (LEAP) Study Team. Identifying infants at high risk of peanut allergy: the Learning Early About Peanut Allergy (LEAP) screening study. J Allergy Clin Immunol. 2013 Jan;131(1):135-43.e1-12. doi: 10.1016/j.jaci.2012.09.015. Epub 2012 Nov 19.
Feeney M, Du Toit G, Roberts G, Sayre PH, Lawson K, Bahnson HT, Sever ML, Radulovic S, Plaut M, Lack G; Immune Tolerance Network LEAP Study Team. Impact of peanut consumption in the LEAP Study: Feasibility, growth, and nutrition. J Allergy Clin Immunol. 2016 Oct;138(4):1108-1118. doi: 10.1016/j.jaci.2016.04.016. Epub 2016 Jun 10.
Roberts G, Bahnson HT, Du Toit G, O'Rourke C, Sever ML, Brittain E, Plaut M, Lack G. Defining the window of opportunity and target populations to prevent peanut allergy. J Allergy Clin Immunol. 2023 May;151(5):1329-1336. doi: 10.1016/j.jaci.2022.09.042. Epub 2022 Dec 12.
Study Documents
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Document Type: Study summary, -design, -adverse event(s), -demographics, -study files
ImmPort study identifier is SDY660
View DocumentDocument Type: Individual Participant Data Set
TrialShare study identifier is LEAP (ITN032AD)
View DocumentDocument Type: Overview, Date & Reports, Manuscripts et al.
TrialShare study identifier is LEAP (ITN032AD)
View DocumentRelated Links
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Immune Tolerance Network website
LEAP Study informational website
National Institute of Allergy and Infectious Diseases (NIAID)
Other Identifiers
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DAIT ITN032AD
Identifier Type: -
Identifier Source: org_study_id
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