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Immunotherapy

Low-Dose Multi-Oral Immunotherapy for Food Allergies (LoMO Trial)

Phase 2
Waitlist Available
Led By Julia Upton
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Positive oral food challenge (OFC) to less than 300mg of a nut in the nut mix at baseline (cumulative 444mg).
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
Must not have
history of eosinophilic gastrointestinal disease, uncontrolled asthma as defined by Global Initiative for Asthma (GINA)
use of beta-blockers(oral)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 18
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if giving nut-allergic children very small amounts of multiple nuts can help them tolerate these nuts without allergic reactions. The goal is to make their immune system get used to the nuts over time.

Who is the study for?
This trial is for children with allergies to 2-5 types of nuts, confirmed by blood tests or skin prick tests, and a positive food challenge. They must not be pregnant, on certain allergy or asthma medications in the past year, have specific gastrointestinal diseases, uncontrolled asthma, severe anaphylaxis history, non-fluency in English, compliance issues or inability to attend regular hospital visits.
What is being tested?
The LoMo trial is testing whether low doses of multiple allergens can help children with nut allergies without causing significant reactions. It aims to see if this approach is safer and more feasible than current high-dose single-allergen OIT treatments that often lead to drop-outs.
What are the potential side effects?
Potential side effects may include allergic reactions ranging from mild symptoms like itching or hives to more serious conditions such as difficulty breathing. The lower dose approach seeks to minimize these risks compared to higher dose therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a reaction to a small amount of nuts in a test.
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My allergy test shows I'm sensitive to nuts or my IgE levels are above 0.35 kU/L.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of eosinophilic gastrointestinal disease or uncontrolled asthma.
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I am taking oral beta-blockers.
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I haven't used omalizumab or similar allergy treatments in the last year.
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I have been intubated before due to allergies or asthma.
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I can follow the study's instructions and come to the hospital as needed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner
Secondary study objectives
Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale
Desensitization to allergic food as assessed by maximum tolerated dose
Immunological change in IgG4
Other study objectives
Basophil activation test
Change in allergen specific IgE, and components
Feasibility analysis as assessed by can the patients achieve the maintenance dosing of the allergen mix for OIT
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: multi-OITExperimental Treatment1 Intervention
Low dose OIT with multiple allergens

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Oral Immunotherapy (OIT) works by gradually exposing patients to increasing amounts of the allergen, aiming to desensitize the immune system and increase the threshold for allergic reactions. This process helps patients tolerate small amounts of the allergen without severe reactions, reducing the risk of accidental exposure. Anti-IgE therapies, such as omalizumab, function by binding to IgE antibodies, preventing them from triggering allergic reactions. These treatments can enhance the safety and efficacy of OIT by reducing the risk of severe allergic reactions during desensitization. Together, these therapies offer promising strategies for managing food allergies, potentially improving patients' quality of life and safety.

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
704 Previous Clinical Trials
6,956,859 Total Patients Enrolled
1 Trials studying Food Allergy
121 Patients Enrolled for Food Allergy
Julia UptonPrincipal InvestigatorThe Hospital for Sick Children

Media Library

Multi-OIT (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03799328 — Phase 2
Food Allergy Research Study Groups: multi-OIT
Food Allergy Clinical Trial 2023: Multi-OIT Highlights & Side Effects. Trial Name: NCT03799328 — Phase 2
Multi-OIT (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03799328 — Phase 2
~3 spots leftby Oct 2025