EczemaPhase 2LEAPNCT00329784
Promoting Tolerance to Peanut in High-Risk Children
A Phase 2 study testing Peanut Consumption Group in people with Eczema and Egg Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 4 to 10 months
- Conditions the study is for
- Eczema, Egg Allergy, Food Allergy
- What is being tested?
- Peanut Consumption Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2006to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Able to consume solid food
- Allergy to eggs and/or severe eczema
- Informed consent obtained from parent or guardian.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Evelina Children's Hospital, Guy's & St Thomas' NHS Foundation Trust
London, England, SE1 7EH
About this study
Official title: Induction of Tolerance Through Early Introduction of Peanut in High-Risk Children (ITN032AD)
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.
- Conditions
- Eczema, Egg Allergy, Food Allergy
- Being tested
- Peanut Consumption Group
- Keywords
- peanut allergy, egg allergy, eczema, peanut, allergy, allergies, allergic reaction, anaphylaxis, infants, children
- Medical subject headings
- Eczema, Egg Hypersensitivity, Food Hypersensitivity, Peanut Hypersensitivity, Hypersensitivity, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut Consumption GroupBiological
Also called Bamba
Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
| Study group | Role | What they receive |
|---|---|---|
| Peanut Consumption Group | Experimental | Participants on this arm will consume peanut protein. Receives: Biological: Peanut Consumption Group |
| Peanut Avoidance Group | No intervention | Participants on this arm will avoid peanut as per United Kingdom (UK) public health recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 60 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startDec 2006
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Responsible party
- Sponsor
- Investigators
- Gideon Lack, MD, Principal investigator, Imperial College, St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329784
- Sponsor's protocol ID
- DAIT ITN032AD
- Acronym
- LEAP
- Status last verified
- Apr 2019
- First submitted
- 23 May 2006
- Last updated
- 17 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- 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).
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 16670515Santos 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 25956314Du 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 26942922Du 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.
PubMed 25705822Gruchalla 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 25705823Du 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 23174658Feeney 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 27297994Kanchan 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.
PubMed 41615410Roberts 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.
PubMed 36521802
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Tolerance Through Early Introduction of Peanut in High-Risk Children (ITN032AD)
- ClinicalTrials.gov ID
- NCT00329784
- Acronym / sponsor ID
- LEAP / DAIT ITN032AD
- Conditions
- Eczema, Egg Allergy, Food Allergy
- Keywords
- peanut allergy, egg allergy, eczema, peanut, allergy, allergies, allergic reaction, anaphylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Study start
- Dec 2006
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 May 2006 (estimated)
- Results
- Posted 28 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut Consumption Group | Experimental | Biological: Peanut Consumption GroupParticipants 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. |
Who may qualify
- Ages
- 4 to 10 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Able to consume solid food
- Allergy to eggs and/or severe eczema
- Informed consent obtained from parent or guardian.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut Consumption GroupAlso: BambaPeanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings. | Biological | Peanut Consumption Group |
Primary outcome
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.
5 secondary outcomes
SCORAD at 60 Months
Time frame: 60 months
Number of Participants With Asthma at 60 Months
Time frame: 60 months
Number of Participants With Rhinitis at 60 Months
Time frame: 60 months
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm
Time frame: 60 months
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L
Time frame: 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16670515Palmer 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.
- Background: PubMed 25956314Santos 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.
- Background: PubMed 26942922Du 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.
- Results publication: PubMed 25705822Du 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.
- Results publication: PubMed 25705823Gruchalla 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.
- Results publication: PubMed 23174658Du 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.
- Results publication: PubMed 27297994Feeney 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.
- Derived from this study: PubMed 41615410Kanchan 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.
- Derived from this study: PubMed 36521802Roberts 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.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Immune Tolerance Network websiteLink provided by the sponsor.
- LEAP Study informational websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gideon Lack, MD principal investigator
Imperial College, St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peanut Consumption Group in people with Eczema and Egg Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum (time frame: 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00329784, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.