Predictors of Persistent Peanut Allergy at Age 5 Years (NCT02497261) | Clinical Trial Compass
By InvitationNot Applicable
Predictors of Persistent Peanut Allergy at Age 5 Years
200 participantsStarted 2015-07
Plain-language summary
The purpose of this study is to determine if avoidance of peanut by children with positive allergy testing to peanut in the first 5 years of life increases the likelihood of developing a persistent peanut allergy by age 5 years. To answer this question, the investigators need to determine which children with positive allergy testing to peanut have reactions after eating peanut (allergic to peanut) and which are able to tolerate eating peanut (not allergic).
The investigators plan to conduct double-blind placebo-controlled peanut challenges (gold standard for peanut allergy diagnosis) for CHILD study (http://www.canadianchildstudy.ca) participants who had positive skin prick testing to peanut at ages 1, 3 or 5 years (in other words, children who are sensitized to peanut, but may or may not be allergic to peanut) and who are avoiding peanut without ever having had a reaction or whose history suggests that they may have outgrown a known peanut allergy. These challenges will not change a child's ability to tolerate peanut, but will determine if children who are avoiding peanut are allergic to peanut (and need to continue avoiding peanut) or clinically tolerant to peanut (and may continue to eat peanut after passing the challenge).
Who can participate
Age range
4 Years – 10 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
. Have completed their 5-year-old CHILD Study visit
. Are or have been sensitized to peanut i.e. have had a positive skin prick test (wheal diameter at least 2 mm greater than the negative control) and/or allergen-specific IgE level (\>0.35 kU/L) to peanut at their 1-, 3- and/or 5-year-old CHILD study visit
. Are not eating peanut. Children who eat less than 8-10 g of peanut per month or who eat only foods that 'may contain' traces of peanut will still be eligible for inclusion.
Exclusion criteria
. They have never had a positive skin prick test or allergen-specific IgE level to peanut
. They are eating 8-10 g of peanut at least once per month, despite having had a positive skin prick test or allergen-specific IgE level to peanut
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
1
Clinical tolerance to peanut (passing a peanut challenge and eating peanut regularly)
. They have a peanut skin prick test wheal size \>8mm and/or a peanut-specific IgE \>15 kU/L and a history suggestive of an IgE-mediated allergic reaction to peanut.
. They have a history of anaphylaxis to peanut or a challenge-proven diagnosis of peanut allergy within the past 1-2 years.
. They have uncontrolled asthma or any other contraindication to performing a DBPC food challenge on the day of challenge. These children may be rescheduled if their asthma control improves.
. Have completed their 5-year-old CHILD Study visit
. Are or have been sensitized to peanut i.e. have had a positive skin prick test (wheal diameter at least 2 mm greater than the negative control) and/or allergen-specific IgE level (\>0.35 kU/L) to peanut at their 1-, 3- and/or 5-year-old CHILD study visit