Low Dose Multi-OIT for Food Allergy (LoMo)

This is a single-arm, open label, study of the intervention of low dose multiple-nut OIT in nut allergic children.

After meeting eligibility criteria, participants will have a food challenge to 2-5 nuts.

If the oral food challenge is positive, participants will be enrolled in the study to multiple nut OIT. A blood draw and quality of life (QOL) survey will occur at baseline.

Participants will have dose escalation visits of the multiple nut OIT every 2 months to a target dose of 30mg of each nut protein. A blood draw and QOL survey will occur at 6 months.

Participants will then continue with daily ingestion of the 30mg of each nut protein for 1 year with visits every 3 months.

After 18 months from the start of the study, another oral food challenge will be given to participants to assess the change in the maximum tolerated dose of nuts. A blood draw will assess changes in the immune parameters. A QOL survey will occur at 18 months to assess changes in QOL.

Inclusion criteria

• Relevant allergy to 2-5 nuts
• Serum immunoglobulin E (IgE) >0.35 kilounits/L (kU/L) (determined by UniCAP within the past 12 months) and/or a SPT to nut >3 mm compared to control
• Positive oral food challenge (OFC) to less than 300mg of a nut in the nut mix at baseline (cumulative 444mg).

Exclusion criteria

• History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
• use of omalizumab or other non-traditional forms of allergen immunomodulatory therapy (not including corticosteroids) or biologic therapy in the 12 months prior to study entry
• history of eosinophilic gastrointestinal disease, uncontrolled asthma as defined by Global Initiative for Asthma (GINA)
• use of beta-blockers(oral)
• use of angiotensin-converting enzyme inhibitors (ACE)
• fails to tolerate 4mg of peanut after the first desensitization day
• Other significant medical conditions that in the opinion of the investigator prevent participation in the study,
• Previous intubation due to allergies or asthma,
• Symptomatic atopic dermatitis or chronic urticaria which may interfere with ability to evaluate oral immunotherapy and /or requiring daily medication including antihistamines,
• Patients with problems related to compliance or following study instructions, Inability to come to hospital every for dose escalation
• Pregnancy
• Non-fluency in English because participants may need to communicate with us after hours and be able to describe symptoms and concerns and follow instructions to treat anaphylaxis