CompletedPhase 2

Low Dose Multi-OIT for Food Allergy (LoMo)

Canada18 participantsStarted 2019-05-23

Plain-language summary

Oral immunotherapy (OIT) is a food allergy treatment where small amounts of the food a child is allergic to is eaten and gradually increased over time with the aim to be able to eat a certain amount of the allergen without experiencing an allergic reaction. While this process works in many children there are concerns about safety, feasibility and drop-outs and how to adapt protocols for multiple allergies. Many OIT trials have targeted approximately 4000mg of single food/day. In these trials up to 40% drop-out. There is evidence much lower doses can have beneficial effects. The investigators will evaluate if low doses of foods can allow for OIT to multiple foods. This approach may have efficacy against accidental exposure and be able to demonstrate immune changes. This approach may have a low burden of treatment and a low rate of allergic reactions and

Who can participate

Age range6 Months – 15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner

Timeframe: month 0, month 18

Immunological change in IgG4

Timeframe: month 0, month 18

Trial details

NCT IDNCT03799328

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-01