Food Oral Immunotherapy for Peanut Allergy

Mass General Brigham

Status and phase

Invitation-only

Phase 2

Conditions

Peanut Allergy

Treatments

Drug: Peanut oral immunotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04222491

2019P003564

Details and patient eligibility

About

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.

Full description

In this research study the investigators want to learn more about the experience of participants with peanut allergy and their caregivers undergoing food oral immunotherapy (OIT) for peanut allergy. Food oral immunotherapy (OIT) is a treatment for individuals with a food allergy to reduce the body's allergic response to the food allergen, resulting in fewer symptoms. The treatment is also called desensitization. An individual becomes desensitized to the food allergen by ingesting small amounts of the food that are slowly increased. Over time, this helps the body's immune system become used to the food so that it no longer causes an allergic reaction. By desensitizing to peanut, it may lower the risk of life-threatening allergic reactions and cause a decreased sensitivity to peanut. The investigators specifically want to learn more about the effects of food OIT on quality of life and other outcomes important to participants with peanut allergy and their caregivers and to ultimately develop tests to predict who may respond favorably to food OIT.

Enrollment

500 estimated patients

Sex

All

Ages

6 months to 65 years old

Volunteers

No Healthy Volunteers

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