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
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.
503 studies on the registry are indexed under Eczema; 89 are open to participants now.
This study's enrollment of 640 is above the median of 91 across 401 interventional studies indexed under Eczema.
Browse Eczema studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants on this arm will consume peanut protein.
Biological: Peanut Consumption Group
Participants on this arm will avoid peanut as per United Kingdom (UK) public health recommendations.
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
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
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
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
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
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
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
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
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.
| Milestone | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group |
|---|---|---|---|---|
| Started | 270 | 272 | 51 | 47 |
| Completed | 265 | 267 | 51 | 47 |
| Not completed | 5 | 5 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 4 | 2 | 0 | 0 |
| Withdrew: Other | 1 | 2 | 0 | 0 |
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.
| Participants | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group |
|---|---|---|---|---|
| Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum | 36 | 5 | 18 | 5 |
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.
| Participants | Peanut Avoidance Group | Peanut Consumption Group |
|---|---|---|
| Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined | 54 | 10 |
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.
| units on a scale | Peanut Avoidance Group | Peanut Consumption Group |
|---|---|---|
| SCORAD at 60 Months | 7.6 ± 11.6 | 6.6 ± 10.7 |
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.
| Participants | Peanut Avoidance Group | Peanut Consumption Group |
|---|---|---|
| Number of Participants With Asthma at 60 Months | 50 | 54 |
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).
| Participants | Peanut Avoidance Group | Peanut Consumption Group |
|---|---|---|
| Seasonal Rhinoconjunctivitis | 106 | 115 |
| Perennial Rhinoconjunctivitis | 134 | 132 |
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.
| Participants | Peanut Avoidance Group | Peanut Consumption Group |
|---|---|---|
| Peanut Wheal | 71 | 30 |
| Egg Wheal | 96 | 102 |
| Milk Wheal | 28 | 25 |
| Sesame Wheal | 22 | 22 |
| Brazil nut Wheal | 29 | 26 |
| Hazel nut Wheal | 34 | 41 |
| Cashew Wheal | 42 | 59 |
| Walnut Wheal | 27 | 34 |
| Almond Wheal | 42 | 50 |
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.
| Participants | Peanut Avoidance Group | Peanut Consumption Group |
|---|---|---|
| Peanut IgE | 93 | 88 |
| Egg IgE | 120 | 114 |
| Milk IgE | 99 | 105 |
| Sesame IgE | 89 | 104 |
| Brazil nut IgE | 45 | 55 |
| Hazel nut IgE | 101 | 116 |
| Cashew IgE | 61 | 73 |
| Walnut IgE | 52 | 70 |
| Almond IgE | 62 | 71 |
Collected over Enrollment through last study visit (up to five years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 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%) |
| Event | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group |
|---|---|---|---|---|
| Anaphylactic reactionImmune system disorders | 5/270 | 0/272 | 7/51 | 3/47 |
| WheezingRespiratory, thoracic and mediastinal disorders | 17/270 | 18/272 | 6/51 | 6/47 |
| Food allergyImmune system disorders | 0/270 | 2/272 | 0/51 | 2/47 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 4/270 | 9/272 | 2/51 | 2/47 |
| Eczema herpeticumInfections and infestations | 0/270 | 1/272 | 1/51 | 1/47 |
| GastroenteritisInfections and infestations | 4/270 | 3/272 | 1/51 | 1/47 |
| Lower respiratory tract infectionInfections and infestations | 1/270 | 0/272 | 0/51 | 1/47 |
| Urinary tract infection pseudomonalInfections and infestations | 0/270 | 0/272 | 0/51 | 1/47 |
| Forearm fractureInjury, poisoning and procedural complications | 0/270 | 1/272 | 0/51 | 1/47 |
| Lung consolidationRespiratory, thoracic and mediastinal disorders | 0/270 | 0/272 | 0/51 | 1/47 |
| Event | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group |
|---|---|---|---|---|
| Food allergyImmune system disorders | 125/270 | 132/272 | 38/51 | 29/47 |
| RhinitisInfections and infestations | 146/270 | 144/272 | 38/51 | 33/47 |
| Upper respiratory tract infectionInfections and infestations | 160/270 | 191/272 | 26/51 | 31/47 |
| GastroenteritisInfections and infestations | 139/270 | 173/272 | 29/51 | 27/47 |
| EczemaSkin and subcutaneous tissue disorders | 141/270 | 147/272 | 21/51 | 27/47 |
| VaricellaInfections and infestations | 119/270 | 145/272 | 23/51 | 17/47 |
| Lower respiratory tract infectionInfections and infestations | 98/270 | 83/272 | 19/51 | 20/47 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 60/270 | 68/272 | 16/51 | 17/47 |
| UrticariaSkin and subcutaneous tissue disorders | 31/270 | 54/272 | 9/51 | 17/47 |
| WheezingRespiratory, thoracic and mediastinal disorders | 65/270 | 58/272 | 18/51 | 15/47 |
Intent-to-treat
| Age, Continuous(Months) | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group | Total |
|---|---|---|---|---|---|
| Mean | 7.7 ± 1.7 | 7.7 ± 1.8 | 8.4 ± 1.7 | 7.9 ± 1.6 | 7.8 ± 1.7 |
| Sex: Female, Male(Participants) | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group | Total |
|---|---|---|---|---|---|
| Female | 96 | 124 | 17 | 19 | 256 |
| Male | 174 | 148 | 34 | 28 | 384 |
| Region of Enrollment(Participants) | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group | Total |
|---|---|---|---|---|---|
| United Kingdom | 270 | 272 | 51 | 47 | 640 |
| Severe Eczema(Participants) | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group | Total |
|---|---|---|---|---|---|
| Count of participants | 236 | 246 | 48 | 41 | 571 |
| Age at Onset of Eczema(Months) | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group | Total |
|---|---|---|---|---|---|
| Mean | 2.2 ± 1.7 | 2.3 ± 1.6 | 2.1 ± 1.6 | 2.4 ± 1.5 | 2.3 ± 1.6 |
| SCORAD(units on a scale) | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group | Total |
|---|---|---|---|---|---|
| Mean | 35.0 ± 19.9 | 33.3 ± 18.4 | 33.7 ± 16.2 | 37.8 ± 18.6 | 34.4 ± 18.9 |
| Total IgE(kUA/L) | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group | Total |
|---|---|---|---|---|---|
| Mean | 95.1 ± 321.8 | 76.4 ± 181.4 | 125.7 ± 174.8 | 306.4 ± 666.5 | 104.8 ± 307.9 |
| Peanut-specific IgE(kUA/L) | Negative Stratum - Peanut Avoidance Group | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group | Total |
|---|---|---|---|---|---|
| Median | 0.0 (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) |
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).
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.
Data sharing details ↗ · www.itntrialshare.org
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