Promoting Tolerance to Peanut in High-Risk Children (LEAP)
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| ClinicalTrials.gov Identifier: NCT00329784 |
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Recruitment Status :
Completed
First Posted : May 25, 2006
Results First Posted : December 28, 2016
Last Update Posted : April 17, 2019
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Eczema Egg Allergy Food Allergy | Biological: Peanut Consumption Group | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 640 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Induction of Tolerance Through Early Introduction of Peanut in High-Risk Children (ITN032AD) |
| Study Start Date : | December 2006 |
| Actual Primary Completion Date : | May 2014 |
| Actual Study Completion Date : | May 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Peanut Consumption Group
Participants on this arm will consume peanut protein.
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Biological: 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 Name: Bamba |
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No Intervention: Peanut Avoidance Group
Participants on this arm will avoid peanut as per United Kingdom (UK) public health recommendations.
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- Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum [ Time Frame: 60 months ]At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.
- Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined [ Time Frame: 60 months ]At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.
- SCORAD at 60 Months [ Time Frame: 60 months ]At 60 months of age, participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD). This measure was used to detect eczema in children who may not have had access to topical anti-inflammatory medications or whose parents cannot recall or report the severity of their child's eczema. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
- Number of Participants With Asthma at 60 Months [ Time Frame: 60 months ]At 60 months of age, participants were assessed for asthma. Participants were considered to have asthma if they had a history of cough, wheeze, or shortness of breath that (1) was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months, (2) required one visit to a physician in the previous 24 months, or (3) occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months.
- Number of Participants With Rhinitis at 60 Months [ Time Frame: 60 months ]At 60 months of age, participants were assessed for rhinitis. Two types of rhinitis were assessed, perennial rhinoconjunctivitis and seasonal rhinoconjunctivitis. Participants were considered to have either type of rhinitis if they showed a sensitization to the allergen and clinical history of rhinoconjunctivitis symptoms experienced either when exposed to the relevant allergen (perennial) or during the relevant season (seasonal).
- Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm [ Time Frame: 60 months ]At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific sensitivity if a skin prick containing the allergen produced a wheal size measuring greater than or equal to 3 mm.
- Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L [ Time Frame: 60 months ]At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific food sensitivity if a blood draw showed specific IgE levels greater than or equal to 0.35 kU/L for selected ingested allergens.
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| Ages Eligible for Study: | 4 Months to 10 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Able to consume solid food
- Allergy to eggs and/or severe eczema
- Informed consent obtained from parent or guardian.
Exclusion Criteria:
- Clinically significant chronic illness. Participants with eczema or recurrent wheeze are not excluded.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329784
| United Kingdom | |
| Evelina Children's Hospital, Guy's & St Thomas' NHS Foundation Trust | |
| London, England, United Kingdom, SE1 7EH | |
| Principal Investigator: | Gideon Lack, MD | Imperial College, St. Mary's Hospital |
Study Data/Documents: Individual Participant Data Set
ImmPort study identifier is SDY660
ImmPort study identifier is SDY660
TrialShare study identifier is LEAP (ITN032AD)
TrialShare study identifier is LEAP (ITN032AD)
Publications of Results:
Other Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00329784 |
| Other Study ID Numbers: |
DAIT ITN032AD |
| First Posted: | May 25, 2006 Key Record Dates |
| Results First Posted: | December 28, 2016 |
| Last Update Posted: | April 17, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The plan is to share data in: 1.)ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online; and 2.)TrialShare, a clinical trials research portal of the Immune Tolerance Network (ITN). |
| Time Frame: | Data sets et al of the manuscript are available to the public in TrialShare. |
| Access Criteria: | The study ID in TrialShare is LEAP ITN032AD. Access is available to the public. |
| URL: | https://www.itntrialshare.org/project/Studies/ITN032ADPUBLIC/Study%20Data/begin.view?pageId=study.DATA_ANALYSIS |
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peanut allergy egg allergy eczema peanut allergy |
allergies allergic reaction anaphylaxis infants children |
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Eczema Hypersensitivity Food Hypersensitivity Egg Hypersensitivity Immune System Diseases |
Dermatitis Skin Diseases Skin Diseases, Eczematous Hypersensitivity, Immediate |