Status:
COMPLETED
Low Dose Multi-OIT for Food Allergy (LoMo)
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Food Allergy
Eligibility:
All Genders
6-15 years
Phase:
PHASE2
Brief 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 o...
Detailed Description
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03799328
Start Date
May 23 2019
End Date
April 1 2025
Last Update
May 21 2025
Active Locations (1)
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1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8