Food Oral Immunotherapy for Peanut Allergy

Running, not enrolling

Conditions studied: Peanut Allergy

In brief

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.

Key facts

Study ID

NCT04222491

Run by

Massachusetts General Hospital

People needed

500

Starts

2020-06-25

Expected to finish

2026-12-01

Last updated by the study team

2026-04-09

Who can join

Age: 1 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 for any reason

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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