This is an open label observational single center study of clinical food oral immunotherapy outcomes with biomarker samples and participant and/or caregiver-completed questionnaires in participants between 6 months and 65 years of age with IgE-mediated peanut allergy undergoing food oral immunotherapy.
Who can participate
Age range6 Months ā 65 Years
SexALL
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Inclusion Criteria:
* Individuals between 6 months and 65 years of age with a diagnosis of immunoglobulin E (IgE)-mediated peanut allergy and their caregivers; a diagnosis of IgE-mediated peanut allergy is defined by: (1) documented history of peanut allergy or determined to be allergic by oral food challenge; (2) evidence of peanut-specific IgE by either: positive skin prick test to peanut allergen (reaction wheal at least 3 mm larger than saline control) or serum peanut-specific IgE \> 0.34 kilo-unit/liter (kU/L) or international unit/milliliter (IU/mL) at screening visit
* Referral by Massachusetts General Hospital (MGH) allergist for food oral immunotherapy
* Willing to sign informed consent or whose caregiver is willing to sign the informed consent (age appropriate)
* Willing to sign the assent form, if age appropriate
Exclusion Criteria:
* History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
* Severe or poorly controlled asthma
* Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, such as inflammatory bowel diseases and eosinophilic gastrointestinal disorders
* Current use of beta blocker medication(s)
* Inability to cooperate with and/or perform oral food challenge procedures
* Females who are pregnant, planning to become pregnant, or breastfeeding
* Investigator determination of safety concern ā¦
What they're measuring
1
The proportion of participants who tolerate the maintenance dose of 300 mg peanut protein with no symptoms within two years of starting OIT