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NCT02497261

Predictors of Persistent Peanut Allergy at Age 5 Years

Sponsor: University of Manitoba

View on ClinicalTrials.gov

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).

Official title: Early Life Origins of the Food Allergy Epidemic: Predictors of Persistent Peanut Allergy at Age 5 Years

Key Details

Gender

All

Age Range

4 Years - 10 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2015-07

Completion Date

2025-12

Last Updated

2025-04-04

Healthy Volunteers

Conditions

Allergy to Peanut

Interventions

PROCEDURE

Double-blind placebo-controlled peanut challenge

Children who are avoiding peanut will be gradually introduced to smoothies containing and not containing peanut, to see if they are able to tolerate eating peanut. This challenge does not change a child's ability to tolerate peanut, but will determine which children avoiding peanut are allergic to peanut and which children are not allergic and may begin eating peanut.

Challenge Inclusion Criteria: CHILD study participants will be eligible for challenge if they 1. Have completed their 5-year-old CHILD Study visit 2. 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 3. 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. Challenge Exclusion Criteria: CHILD study participants will be ineligible for challenge if 1. They have never had a positive skin prick test or allergen-specific IgE level to peanut 2. 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 3. Their family has declined to participate 4. 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. 5. They have a history of anaphylaxis to peanut or a challenge-proven diagnosis of peanut allergy within the past 1-2 years. 6. 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. Blood Draw Inclusion Criteria: CHILD study participants will be eligible for blood draw if they 1. Have completed their 5-year-old CHILD Study visit 2. 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 Blood Draw Exclusion Criteria: CHILD study participants will be ineligible for blood draw if 1. They have never had a positive skin prick test or allergen-specific IgE level to peanut 2. Their family has declined to participate Immunological analyses of the blood samples are underway now that the 2 sites participating in this portion of the study (University of Manitoba and University of British Columbia) have completed their challenges. Challenges were halted in the spring.