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CompletedNCT00329784LEAPUpdated Apr 17, 2019Results posted

Promoting Tolerance to Peanut in High-Risk Children

A Phase 2 interventional study of Peanut Consumption Group in Eczema, Egg Allergy and Food Allergy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United Kingdom. Open to participants aged 4 Months to 10 Months. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
640
Allocation
Randomized
Ages
4 Months to 10 Months
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Eczema
  • Egg Allergy
  • Food Allergy

Keywords

  • peanut allergy
  • egg allergy
  • eczema
  • peanut
  • allergy
  • allergies
  • allergic reaction
  • anaphylaxis
  • infants
  • children
03

Who can participate

Ages eligible
4 Months to 10 Months
Sexes eligible
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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
640 participants (actual)

Study arms

  • Experimental
    Peanut Consumption Group

    Participants on this arm will consume peanut protein.

    Biological: Peanut Consumption Group

  • No intervention
    Peanut Avoidance Group

    Participants on this arm will avoid peanut as per United Kingdom (UK) public health recommendations.

Interventions

  • BiologicalPeanut 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.

    Also known as: Bamba

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 60 months

  2. 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.

    Time frame: 60 months

Secondary outcomes

  1. 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.

    Time frame: 60 months

  2. 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.

    Time frame: 60 months

  3. 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).

    Time frame: 60 months

  4. 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.

    Time frame: 60 months

  5. 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.

    Time frame: 60 months

06

Results

Posted Dec 28, 2016

Participant flow

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.

Participant flow — Overall Study
MilestoneNegative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption Group
Started2702725147
Completed2652675147
Not completed5500
Withdrew: Lost to follow-up0100
Withdrew: Withdrawal by subject4200
Withdrew: Other1200

Outcome measures

PrimaryNumber 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.

Time frame:
60 months
Reported as:
Count of participants · Participants
Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum
ParticipantsNegative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption Group
Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum365185
Statistical analysis
  • Negative Stratum - Peanut Avoidance Group vs Negative Stratum - Peanut Consumption Group · Chi-squared · p = <0.0001
  • Positive Stratum - Peanut Avoidance Group vs Positive Stratum - Peanut Consumption Group · Chi-squared · p = 0.004
PrimaryNumber 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.

Time frame:
60 months
Reported as:
Count of participants · Participants
Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined
ParticipantsPeanut Avoidance GroupPeanut Consumption Group
Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined5410
Statistical analysis
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = <0.0001
SecondarySCORAD 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.

Time frame:
60 months
Reported as:
Mean · units on a scale
SCORAD at 60 Months
units on a scalePeanut Avoidance GroupPeanut Consumption Group
SCORAD at 60 Months7.6 ± 11.66.6 ± 10.7
Statistical analysis
  • Peanut Avoidance Group vs Peanut Consumption Group · Wilcoxon (Mann-Whitney) · p = 0.369
SecondaryNumber 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.

Time frame:
60 months
Reported as:
Count of participants · Participants
Number of Participants With Asthma at 60 Months
ParticipantsPeanut Avoidance GroupPeanut Consumption Group
Number of Participants With Asthma at 60 Months5054
Statistical analysis
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.642
SecondaryNumber 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).

Time frame:
60 months
Reported as:
Count of participants · Participants
Number of Participants With Rhinitis at 60 Months
ParticipantsPeanut Avoidance GroupPeanut Consumption Group
Seasonal Rhinoconjunctivitis106115
Perennial Rhinoconjunctivitis134132
Statistical analysis
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.417
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.926
SecondaryNumber 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.

Time frame:
60 months
Reported as:
Count of participants · Participants
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm
ParticipantsPeanut Avoidance GroupPeanut Consumption Group
Peanut Wheal7130
Egg Wheal96102
Milk Wheal2825
Sesame Wheal2222
Brazil nut Wheal2926
Hazel nut Wheal3441
Cashew Wheal4259
Walnut Wheal2734
Almond Wheal4250
Statistical analysis
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = <0.001
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.361
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.760
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.834
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.882
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.226
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.024
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.204
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.194
SecondaryNumber 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.

Time frame:
60 months
Reported as:
Count of participants · Participants
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L
ParticipantsPeanut Avoidance GroupPeanut Consumption Group
Peanut IgE9388
Egg IgE120114
Milk IgE99105
Sesame IgE89104
Brazil nut IgE4555
Hazel nut IgE101116
Cashew IgE6173
Walnut IgE5270
Almond IgE6271
Statistical analysis
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.859
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.885
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.403
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.106
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.202
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.108
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.157
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.040
  • Peanut Avoidance Group vs Peanut Consumption Group · Chi-squared · p = 0.262

Adverse events

Collected over Enrollment through last study visit (up to five years). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Negative Stratum - Peanut Avoidance Group—55/270 (20.4%)268/270 (99.3%)
Negative Stratum - Peanut Consumption Group—47/272 (17.3%)271/272 (99.6%)
Positive Stratum - Peanut Avoidance Group—15/51 (29.4%)51/51 (100%)
Positive Stratum - Peanut Consumption Group—14/47 (29.8%)47/47 (100%)
Most frequent serious events
Showing 10 of 46
Most frequent serious events
EventNegative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption Group
Anaphylactic reactionImmune system disorders5/2700/2727/513/47
WheezingRespiratory, thoracic and mediastinal disorders17/27018/2726/516/47
Food allergyImmune system disorders0/2702/2720/512/47
AsthmaRespiratory, thoracic and mediastinal disorders4/2709/2722/512/47
Eczema herpeticumInfections and infestations0/2701/2721/511/47
GastroenteritisInfections and infestations4/2703/2721/511/47
Lower respiratory tract infectionInfections and infestations1/2700/2720/511/47
Urinary tract infection pseudomonalInfections and infestations0/2700/2720/511/47
Forearm fractureInjury, poisoning and procedural complications0/2701/2720/511/47
Lung consolidationRespiratory, thoracic and mediastinal disorders0/2700/2720/511/47
Most frequent other events
Showing 10 of 29
Most frequent other events
EventNegative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption Group
Food allergyImmune system disorders125/270132/27238/5129/47
RhinitisInfections and infestations146/270144/27238/5133/47
Upper respiratory tract infectionInfections and infestations160/270191/27226/5131/47
GastroenteritisInfections and infestations139/270173/27229/5127/47
EczemaSkin and subcutaneous tissue disorders141/270147/27221/5127/47
VaricellaInfections and infestations119/270145/27223/5117/47
Lower respiratory tract infectionInfections and infestations98/27083/27219/5120/47
AsthmaRespiratory, thoracic and mediastinal disorders60/27068/27216/5117/47
UrticariaSkin and subcutaneous tissue disorders31/27054/2729/5117/47
WheezingRespiratory, thoracic and mediastinal disorders65/27058/27218/5115/47

Baseline characteristics

Intent-to-treat

Age, Continuous
Age, Continuous(Months)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
Mean7.7 ± 1.77.7 ± 1.88.4 ± 1.77.9 ± 1.67.8 ± 1.7
Sex: Female, Male
Sex: Female, Male(Participants)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
Female961241719256
Male1741483428384
Region of Enrollment
Region of Enrollment(Participants)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
United Kingdom2702725147640
Severe Eczema
Severe Eczema(Participants)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
Count of participants2362464841571
Age at Onset of Eczema
Age at Onset of Eczema(Months)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
Mean2.2 ± 1.72.3 ± 1.62.1 ± 1.62.4 ± 1.52.3 ± 1.6
SCORAD
SCORAD(units on a scale)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
Mean35.0 ± 19.933.3 ± 18.433.7 ± 16.237.8 ± 18.634.4 ± 18.9
Total IgE
Total IgE(kUA/L)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
Mean95.1 ± 321.876.4 ± 181.4125.7 ± 174.8306.4 ± 666.5104.8 ± 307.9
Peanut-specific IgE
Peanut-specific IgE(kUA/L)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
Median0.0 (0.0 to 0.2)0.0 (0.0 to 0.1)0.4 (0.1 to 3.0)1.3 (0.2 to 5.5)0.0 (0.0 to 0.3)
07

Study locations

1 site
  • Evelina Children's Hospital, Guy's & St Thomas' NHS Foundation Trust
    London, England SE1 7EH, United Kingdom
08

References and documents

Publications

  • 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. PubMed 16670515 ↗
  • 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. PubMed 25956314 ↗
  • 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. PubMed 26942922 ↗
  • 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. Erratum In: N Engl J Med. 2016 Jul 28;375(4):398. doi: 10.1056/NEJMx150044. PubMed 25705822 ↗
  • 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. PubMed 25705823 ↗
  • 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. PubMed 23174658 ↗
  • 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. PubMed 27297994 ↗

Individual participant data

Plan to share: Yes — 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).

09

Registry details

Key details

Study ID
NCT00329784
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immune Tolerance Network (ITN)
Responsible party
Sponsor
First posted
May 25, 2006
Start date
Dec 2006
Primary completion
May 2014
Completion
May 2014
Results posted
Dec 28, 2016
Last update
Apr 17, 2019

Study contacts

Gideon Lack, MD
principal investigator · Imperial College, St. Mary's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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