Food Oral Immunotherapy for Peanut Allergy

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jan 7, 2020

Keywords

ClinConnect Summary

This study at Massachusetts General Hospital is looking at peanut oral immunotherapy (OIT) for people who have a peanut allergy. In simple terms, OIT means gradually eating small, then larger, amounts of peanut to help the body become less sensitive over time. This is an open-label, single-center study, so everyone knows they’re receiving OIT and there isn’t a comparison group. Researchers will collect blood and skin tests and have participants (or their caregivers) answer questionnaires about quality of life to learn how OIT affects daily living, safety, and immune responses.

Who can join? Adults and children from 6 months up to 65 years with a confirmed IgE-mediated peanut allergy who are referred by an MGH allergist and willing to consent (and assent if appropriate). Key exclusions include a recent severe anaphylactic reaction or poorly controlled asthma, other serious medical problems, current beta blocker use, difficulty completing food challenges, or pregnancy. If enrolled, you’ll receive peanut OIT and have regular visits for safety checks, blood tests, skin tests, and questionnaires. The study aims to see if people can reach a maintenance dose of 300 mg peanut protein after about 2 years, how quality of life changes, and whether they can tolerate a 5000 mg dose after 12 months on maintenance. Enrollment is up to 500 participants and the study is expected to continue through 2026. If you’re considering this, talk with your allergist to learn more about eligibility and what to expect.

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ALL

Eligibility criteria

• 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 for any reason