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| Name | Class |
|---|---|
| Immune Tolerance Network (ITN) | NETWORK |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut Consumption Group | Experimental | Participants on this arm will consume peanut protein. |
|
| Peanut Avoidance Group | No Intervention | Participants on this arm will avoid peanut as per United Kingdom (UK) public health recommendations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut Consumption Group | Biological | Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum | 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. | 60 months |
| Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined | 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. | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD at 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gideon Lack, MD | Imperial College, St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evelina Children's Hospital, Guy's & St Thomas' NHS Foundation Trust | London | England | SE1 7EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16670515 | Background | 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. | |
| 25956314 | Background | 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. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SDY660 | Individual Participant Data Set | View IPD |
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).
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Data sets et al of the manuscript are available to the public in TrialShare.
The study ID in TrialShare is LEAP ITN032AD. Access is available to the public.
Participants were stratified into cohorts based on a skin prick test for peanut allergen. Participants were either negative (no measureable wheal after test) or positive (a wheal measuring between 1 and 4 mm in diameter). Participants were then randomized into treatment groups.
Participants between 4 and 11 months of age with pre-existing allergy to egg and/or severe eczema were recruited in the United Kingdom between December 2006 and May 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Negative Stratum - Peanut Avoidance Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| FG001 | Negative Stratum - Peanut Consumption Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. |
| FG002 | Positive Stratum - Peanut Avoidance Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| FG003 | Positive Stratum - Peanut Consumption Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Stratum - Peanut Avoidance Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum | 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. | Intent-to-treat - all randomly assigned participants who were evaluable for peanut allergy at age 60 months | Posted | Count of Participants | Participants | 60 months |
Enrollment through last study visit (up to five years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Negative Stratum - Peanut Avoidance Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
Not provided
| ID | Term |
|---|---|
| D004485 | Eczema |
| D021181 | Egg Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D021183 | Peanut Hypersensitivity |
| D006967 | Hypersensitivity |
| D000707 | Anaphylaxis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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|
| 60 months |
| Number of Participants With Asthma at 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. | 60 months |
| Number of Participants With Rhinitis at 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). | 60 months |
| Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | 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. | 60 months |
| Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | 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. | 60 months |
| 26942922 | Background | 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. |
| 25705822 | Result | 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. |
| 25705823 | Result | 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. |
| 23174658 | Result | 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. |
| 27297994 | Result | 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. |
| 41615410 | Derived | Kanchan K, Cerosaletti K, Perry JA, DuToit G, Manohar M, Ling H, Paschall JE, Sanda S, Chinthrajah RS, Nepom GT, Nadeau KC, Jones SM, Lack G, Ruczinski I, Mathias RA. Genetic Determinants of Peanut-Specific IgG4 Levels in the Context of Sustained Oral Peanut Exposure in the LEAP Study. Immunology. 2026 Jun;178(2):280-292. doi: 10.1111/imm.70098. Epub 2026 Jan 30. |
| 36521802 | Derived | 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. |
| Immune Tolerance Network website | View source |
| LEAP Study informational website | View source |
ImmPort study identifier is SDY660 |
| SDY660 | Study summary, -design, -adverse event(s), -demographics, -study files | View IPD | ImmPort study identifier is SDY660 |
| LEAP (ITN032AD) | Individual Participant Data Set | View IPD | TrialShare study identifier is LEAP (ITN032AD) |
| LEAP (ITN032AD) | Overview, Date & Reports, Manuscripts et al. | View IPD | TrialShare study identifier is LEAP (ITN032AD) |
| Withdrawal by Subject |
|
| Other |
|
| Negative Stratum - Peanut Consumption Group |
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. |
| BG002 | Positive Stratum - Peanut Avoidance Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| BG003 | Positive Stratum - Peanut Consumption Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. |
| BG004 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Severe Eczema | Number of participants with severe eczema at baseline. Eczema is any type of dermatitis or inflammation of the skin. Severe eczema for this trial is based on three criteria. The first criterion was the parent or guardians' description of their child's eczema severity. The second criterion was the use of topical creams or ointments containing corticosteroids or calcineurin inhibitors. The third criterion will be a modified Scoring Atopic Dermatitis System (SCORAD). Infants with severe eczema are at a high risk of developing a peanut allergy | Count of Participants | Participants |
|
| Age at Onset of Eczema | Age in months at which eczema symptoms began. Eczema is any type of dermatitis or inflammation of the skin. Severe eczema for this trial is based on three criteria. The first criterion was the parent or guardians' description of their child's eczema severity. The second criterion was the use of topical creams or ointments containing corticosteroids or calcineurin inhibitors. The third criterion will be a modified Scoring Atopic Dermatitis System (SCORAD). Infants with severe eczema are at a high risk of developing a peanut allergy | Mean | Standard Deviation | Months |
|
| SCORAD | A modified Scoring Atopic Dermatitis System (SCORAD) 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. Scores less than 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema. | Mean | Standard Deviation | units on a scale |
|
| Total IgE | Total Immunoglobulin E (IgE) includes the following potential allergens: peanut, hen's egg white, cow's milk, sesame, brazil nut, hazel nut, cashew, almond, walnut, house dust mite, cat dander, dog dander, timothy grass pollen, alternaria mold, and birch tree pollen. IgE is measured in a serum sample. Results <75 kUA/L suggests that the participant is not allergic to any of the potential allergens. A result >75 kUA/L suggests at least a mild clinical allergy. The higher the total IgE present in the serum sample, the more likely it is to be a presence of an allergy to at least one allergen | Mean | Standard Deviation | kUA/L |
|
| Peanut-specific IgE | Immunoglobulin E (IgE) is an antibody produced by the immune system. If you have an allergy, your immune system overreacts to an allergen by producing antibodies called IgE. These antibodies travel to cells that release chemicals, causing an allergic reaction. Peanut-specific IgE is measured in a serum sample following a peanut skin prick test. Results <0.35 kUA/L is considered low level allergic reaction to peanut. Results from >= 0.35 to <15 kUA/L are considered mid-level allergic reaction to peanut. Results >=15 kUA/L are considered high level allergic reaction to peanut. | Median | Inter-Quartile Range | kUA/L |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Negative Stratum - Peanut Avoidance Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| OG001 | Negative Stratum - Peanut Consumption Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. |
| OG002 | Positive Stratum - Peanut Avoidance Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| OG003 | Positive Stratum - Peanut Consumption Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. |
|
|
|
| Primary | Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined | 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. | Intent-to-treat - all randomly assigned participants who were evaluable for peanut allergy at age 60 months | Posted | Count of Participants | Participants | 60 months |
|
|
|
|
| Secondary | SCORAD at 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. | Intent-to-treat with SCORAD data available | Posted | Mean | Standard Deviation | units on a scale | 60 months |
|
|
|
|
| Secondary | Number of Participants With Asthma at 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. | Intent-to-treat with asthma data available | Posted | Count of Participants | Participants | 60 months |
|
|
|
|
| Secondary | Number of Participants With Rhinitis at 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). | Intent-to-treat with rhinitis data available | Posted | Count of Participants | Participants | 60 months |
|
|
|
|
| Secondary | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | 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. | Intent-to-treat with data available | Posted | Count of Participants | Participants | 60 months |
|
|
|
|
| Secondary | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | 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. | Intent-to-treat with data available | Posted | Count of Participants | Participants | 60 months |
|
|
|
|
| 55 |
| 270 |
| 268 |
| 270 |
| EG001 | Negative Stratum - Peanut Consumption Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. | 47 | 272 | 271 | 272 |
| EG002 | Positive Stratum - Peanut Avoidance Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. | 15 | 51 | 51 | 51 |
| EG003 | Positive Stratum - Peanut Consumption Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. | 14 | 47 | 47 | 47 |
| Intussusception | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Allergy to animal | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Milk allergy | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Eczema herpeticum | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Eczema infected | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Measles | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Meningococcal sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Viral tonsillitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Milk allergy | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Eczema infected | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
Not provided
Not provided
| D006969 |
| Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D000074924 | Nut and Peanut Hypersensitivity |
| 0.926 |
| Superiority or Other |
| Egg Wheal |
|
|
| Milk Wheal |
|
|
| Sesame Wheal |
|
|
| Brazil nut Wheal |
|
|
| Hazel nut Wheal |
|
|
| Cashew Wheal |
|
|
| Walnut Wheal |
|
|
| Almond Wheal |
|
|
| 0.361 |
| Superiority or Other |
| Comparison for Milk Wheal | Chi-squared | 0.760 | Superiority or Other |
| Comparison for Sesame Wheal | Chi-squared | 0.834 | Superiority or Other |
| Comparison for Brazil Nut Wheal | Chi-squared | 0.882 | Superiority or Other |
| Comparison for Hazel Nut Wheal | Chi-squared | 0.226 | Superiority or Other |
| Comparison for Cashew Wheal | Chi-squared | 0.024 | Superiority or Other |
| Comparison for Walnut Wheal | Chi-squared | 0.204 | Superiority or Other |
| Comparison for Almond Wheal | Chi-squared | 0.194 | Superiority or Other |
| Egg IgE |
|
|
| Milk IgE |
|
|
| Sesame IgE |
|
|
| Brazil nut IgE |
|
|
| Hazel nut IgE |
|
|
| Cashew IgE |
|
|
| Walnut IgE |
|
|
| Almond IgE |
|
|
| 0.885 |
| Superiority or Other |
| Comparison for Milk IgE | Chi-squared | 0.403 | Superiority or Other |
| Comparison for Sesame IgE | Chi-squared | 0.106 | Superiority or Other |
| Comparison for Brazil Nut IgE | Chi-squared | 0.202 | Superiority or Other |
| Comparison for Hazel Nut IgE | Chi-squared | 0.108 | Superiority or Other |
| Comparison for Cashew IgE | Chi-squared | 0.157 | Superiority or Other |
| Comparison for Walnut IgE | Chi-squared | 0.040 | Superiority or Other |
| Comparison for Almond IgE | Chi-squared | 0.262 | Superiority or Other |