CompletedPhase 2

Persistence of Oral Tolerance to Peanut

United Kingdom556 participantsStarted 2011-05

Plain-language summary

ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784). Peanut Allergy, a recognized public health concern, is a common and potentially life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study evaluated whether early exposure to peanut promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect of twelve months of cessation of peanut consumption in LEAP Study participants who consumed peanut and those who avoided peanut over the previous five years.

Who can participate

Age range

5 Years – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All LEAP Study participants who are evaluable for peanut allergy at year 5 by LEAP (ClinicalTrials.gov ID NCT00329784) Study criteria. * Parent or guardian willing to provide informed consent. Exclusion Criteria: * Unable or unwilling to comply with study intervention and procedures. * Participation in other food allergy intervention trials.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum

Timeframe: 72 months

Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group

Timeframe: 72 months

Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population

Timeframe: 72 months

Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population

Timeframe: 72 months

Trial details

NCT IDNCT01366846

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2015-05

Results submitted2016-11-08

View on ClinicalTrials.gov More Eczema trials

Plain-language summary

Who can participate

Age range

5 Years – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum

Timeframe: 72 months

Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group

Timeframe: 72 months

Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population

Timeframe: 72 months

Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population

Timeframe: 72 months