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

STATUS

Recruiting
End date

Apr 9, 2024
participants needed

74
sponsor

Scott Sicherer

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Updated on 9 April 2022

See if I qualify

remission

sensitisation

allergic response

sensitization

allergy to peanuts

Summary

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.

Details

Condition	Food Allergy, Peanut Allergy
Treatment	Peanut Protein
Clinical Study Identifier	NCT03907397
Sponsor	Scott Sicherer
Last Modified on	9 April 2022

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Eligibility		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
	participants
	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
	peanut
	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
	rhinitis)
	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
	asthma)
	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
	asthma/wheezing
	Allergy to all of the following: oat, rice, corn, tapioca
	Pregnancy
	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
	year
	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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Immune and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy (CAFETERIA)