CompletedPhase 2

Promoting Tolerance to Peanut in High-Risk Children

United Kingdom640 participantsStarted 2006-12

Plain-language 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).

Who can participate

Age range

4 Months – 10 Months

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: * Able to consume solid food * Allergy to eggs and/or severe eczema * Informed consent obtained from parent or guardian. 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

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 at 60 Months of Age - by Skin Prick Test Stratum

Timeframe: 60 months

Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined

Timeframe: 60 months

Trial details

NCT IDNCT00329784

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2014-05

Results submitted2016-11-01

View on ClinicalTrials.gov More Eczema trials

Who can participate

Age range

4 Months – 10 Months

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.