Predictors of Persistent Peanut Allergy at Age 5 Years

NCT02497261 | Enrolling By Invitation

• 1 other identifier: B2015:052
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Allergy to Peanut

Keywords

Food Allergy; Peanut; Sensitization; Child; Double-blind placebo-controlled challenge; Prospective cohort

Outcome Measures

Primary Outcomes (1)

• Clinical tolerance to peanut (passing a peanut challenge and eating peanut regularly)

  Clinical tolerance to peanut (passing a peanut challenge and eating peanut regularly)

  Age 5 years

Study Arms (2)

Avoiding and possibly allergic to peanut

Challenge Group: Children with positive skin prick testing to peanut who are avoiding peanut will undergo a double-blind placebo-controlled peanut challenge (gold standard for peanut allergy diagnosis) if their allergy evaluation suggests that they have a good chance of not being allergic to peanut. Children who pass the challenge are not allergic to peanut. Children who react during the challenge are allergic to peanut and will continue to avoid peanut.

Procedure: Double-blind placebo-controlled peanut challenge

Not allergic to peanut

Comparison Group: Children with positive skin prick testing to peanut who are eating and tolerating peanut are not clinically allergic to peanut and may continue eating peanut.

Interventions

Double-blind placebo-controlled peanut challenge PROCEDURE

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.

Also known as: Tiny 1st peanut dose & scheduled doses increased by 1/2-log, No drugs or devices

Avoiding and possibly allergic to peanut

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from among the participants of the Canadian Healthy Infant Longitudinal Development (CHILD) Study (http://www.canadianchildstudy.ca) who have completed their 5-year-old study visit.

You may qualify if:

• CHILD study participants will be eligible for challenge if they
• 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

You may not qualify if:

• CHILD study participants will be ineligible for challenge if
• 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
• Their family has declined to participate
• 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.
• CHILD study participants will be eligible for blood draw if they
• 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
• CHILD study participants will be ineligible for blood draw if
• They have never had a positive skin prick test or allergen-specific IgE level to peanut
• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• University of British Columbia: collaborator
• The Hospital for Sick Children: collaborator
• McGill University: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for immunological markers of peanut allergy

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Elinor Simons, MD PhD MSc

  Section of Allergy, Department of Pediatrics & Child Health, University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Elinor Simons, Assistant Professor

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04