Immune and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy (CAFETERIA)

  • End date
    Apr 9, 2024
  • participants needed
  • sponsor
    Scott Sicherer
Updated on 9 April 2022
allergic response
allergy to peanuts


The primary objective of this study is to determine whether allowing ingestion of sub-threshold amounts of peanut in those with a high threshold (tolerate at least 143 mg peanut protein on supervised double-blind, placebo-controlled oral food challenge [DBPCFC]) will be associated with attaining even higher thresholds over time in children with high threshold peanut allergy compared to those avoiding peanut. The secondary clinical objectives include assessing the development of sustained unresponsiveness (SU, a surrogate term for tolerance without daily ingestion), effects on quality of life, and safety compared to those avoiding peanut. Additionally, this study will phenotype the allergic response to peanut based on threshold and response to exposure. Mechanistic study objectives will determine the immune and molecular basis of the high threshold endotype, identify predictors of response to exposure, and determine mechanisms and biomarkers of remission.

Condition Food Allergy, Peanut Allergy
Treatment Peanut Protein
Clinical Study IdentifierNCT03907397
SponsorScott Sicherer
Last Modified on9 April 2022


Yes No Not Sure

Inclusion Criteria

Subject and/or parent guardian must be able to understand and provide informed consent
Inclusion criteria for screening DBPCFC
Age 4-14 years
either sex
any race, any ethnicity
who are enrolled while strictly avoiding peanut
have a history of sensitization (detectable peanut IgE >0.35 kUA/L)
Inclusion criteria for randomization
On screening DBPCFC are able to ingest >= 143 mg peanut protein but < 5043 mg peanut protein
All children will have documented consent and assent as is appropriate for age

Exclusion Criteria

Individuals who meet any of these criteria are not eligible for enrollment as study
Inability or unwillingness of a participant to give written informed consent or comply
with study protocol
Serum peanut-specific IgE antibody level > 50 kUA/L
Recent (within the past 2 years) life-threatening (grade 3) anaphylactic reaction to
Any disorder in which epinephrine is contraindicated such as known hypertension or
On a build-up phase of any allergen immunotherapy
cardia rhythm disorders
History of chronic disease requiring therapy (other than asthma, atopic dermatitis
ACT or cACT < 20
For those with a history of asthma, the following are assessed and any of the
Use of steroid medications in the following manners
following is an exclusion (markers of current uncontrolled or moderate to severe
history of daily oral steroid dosing for >1 month during the past year
FEV1 value <80% predicted (only for participants age 7 years or older and are
having 1 burst or steroid course within the past 6 months, or
able to perform spirometry
having >1 burst oral steroid course within the past 12 months
>Step 3 controller therapy as defined for children 0-4, 5-11 and >=12 years of
Gastrointestinal eosinophilic disorders, esophagitis, gastroenteritis
age by EPR-3 tables
Therapy with anti-IgE or other biologics, including within 1 year of enrollment
Asthma requiring >1 hospitalization in the past year for asthma or >1 ED visit in
Use of investigational drugs within 52 weeks of participation
the past 6 months for asthma, or any prior intubation/mechanical ventilation for
Allergy to all of the following: oat, rice, corn, tapioca
Use of short-acting antihistamines (diphenhydramine, etc.) more than one time within 3
days prior to DBPCFC or skin testing
Use of medium-acting antihistamines (hydroxyzine, loratadine, etc.) more than one time
within 7 days of DBPCFC or skin testing
Use of systemic steroid medications (IV, IM or oral) for indications other than asthma
for > 3 weeks within the past 6 months
Use of beta-blockers (oral), (ACE) inhibitors, angiotensin-receptor blockers or
calcium channel blockers
Participation in any trials of therapeutic interventions for food allergy in the past
Past or current medical problems or findings from physical examination or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality or
interpretation of the data obtained from the study
_Any subject meeting these criteria during the visits can be rescheduled for the oral food
challenge or prick skin testing._
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