Low-Dose Multi-Oral Immunotherapy for Food Allergies

(LoMO Trial)

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: The Hospital for Sick Children

Must not be taking: Omalizumab, Beta-blockers, ACE inhibitors

Disqualifiers: Severe anaphylaxis, Uncontrolled asthma, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating multiple food allergies using low doses of foods, known as Multi-OIT (Multi-Oral Immunotherapy). The goal is to determine if consuming small amounts of multiple allergens can help the body tolerate accidental exposure without triggering allergic reactions. The study targets individuals allergic to 2-5 types of nuts who have reacted to even small amounts. This method aims to be safer and easier to maintain compared to higher-dose treatments. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications like omalizumab, beta-blockers, or ACE inhibitors. It's best to discuss your current medications with the trial team to see if they affect your eligibility.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that oral immunotherapy (OIT) using multiple food allergens is possible and generally safe. Administering small amounts of different allergens simultaneously can be done without major safety concerns, especially in a hospital setting where experts can closely monitor patients.

One study compared the use of multiple allergens at once to a single allergen and found both methods generally safe for children. However, OIT can sometimes cause mild allergic reactions, which are usually manageable.

In earlier trials focusing on single allergens like peanuts, eggs, and milk, about 60 to 80% of patients became desensitized, meaning they could eat the food without a reaction. Although detailed data for multiple allergens is not yet available, early results are promising.

Overall, the treatment appears well-tolerated, but like any medical treatment, it carries some risks. Consulting a healthcare provider is always best to understand the potential benefits and risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for food allergies, which often involve complete avoidance of allergens and the use of emergency medications like epinephrine, Multi-Oral Immunotherapy (Multi-OIT) is unique because it introduces a low-dose exposure to multiple allergens at once. This approach aims to build up the body's tolerance to allergens gradually, potentially reducing the severity of allergic reactions over time. Researchers are excited about Multi-OIT because it offers a proactive way to manage food allergies, potentially reducing the need for strict dietary restrictions and minimizing the risk of severe allergic reactions.

What evidence suggests that this trial's treatment could be effective for food allergies?

Research shows that oral immunotherapy (OIT) can help people with food allergies by gradually introducing tiny amounts of the allergen, the substance that triggers the allergy. Previous studies have demonstrated that OIT can increase tolerance to larger amounts of the allergen, but concerns remain about safety and treatment dropout rates. This trial will evaluate low-dose multi-oral immunotherapy (multi-OIT) for multiple allergens. Studies suggest that smaller doses of allergens might still be effective and could reduce the risk of allergic reactions and treatment discontinuation. Specifically, research has found that low-dose OIT for several foods might protect against accidental exposure and lead to positive immune system changes. This method could offer a safer and more manageable option for those with multiple food allergies. ^{2 6 7 8 9}

Who Is on the Research Team?

Julia Upton

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I had a reaction to a small amount of nuts in a test.

My allergy test shows I'm sensitive to nuts or my IgE levels are above 0.35 kU/L.

Relevant allergy to 2-5 nuts

Exclusion Criteria

fails to tolerate 4mg of peanut after the first desensitization day

You have a history of severe and life-threatening episodes of anaphylactic shock happening repeatedly.

I have a history of eosinophilic gastrointestinal disease or uncontrolled asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo a food challenge to 2-5 nuts, blood draw, and quality of life survey

1 day

1 visit (in-person)

Dose Escalation

Participants have dose escalation visits every 2 months to reach a target dose of 30mg of each nut protein

6 months

3 visits (in-person)

Maintenance

Participants continue daily ingestion of 30mg of each nut protein with visits every 3 months

12 months

4 visits (in-person)

Follow-up

Participants undergo an oral food challenge, blood draw, and quality of life survey to assess changes

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Multi-OIT

Trial Overview 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.

How Is the Trial Designed?

Group I: multi-OIT Experimental Treatment 1 Intervention

Low dose OIT with multiple allergens

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Citations

1. jaci-global.org jaci-global.org/article/S2772-8293(24)00178-4/fulltext

ADP101 multifood oral immunotherapy for food-allergic ... The phase 1/2 Harmony trial (NCT04856865) evaluated efficacy and safety of ADP101 in participants with qualifying allergy to 1 to 5 foods in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10079524/

Oral Immunotherapy in Food Allergy: Where Are We Now? Chinthrajah et al. have reported that peanut OIT can desensitize most individuals with peanut allergy to 4,000 mg of peanut protein; however, discontinuation, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537018300610

A Phase 2 Randomized Controlled Multisite Study Using ... Evidence before this study. There are currently no approved treatments for food allergy; however, oral immunotherapy (OIT) for food allergy has shown promise.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330343/

Double-blind, placebo-controlled study of E-B-FAHF-2 in ... However, outcomes were not improved by addition of E-B-FAHF-2. Keywords: Chinese herbal therapy, E-B-FAHF-2, desensitization, food allergy, peanut allergy, ...

5. aacijournal.biomedcentral.com aacijournal.biomedcentral.com/articles/10.1186/1710-1492-10-1

Safety and feasibility of oral immunotherapy to multiple ... Previous studies on oral immunotherapy (OIT) for food allergy have focused on the administration of a single allergen at the time. This study ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24428859/

Safety and feasibility of oral immunotherapy to multiple ... Preliminary data show oral immunotherapy using multiple food allergens simultaneously to be feasible and relatively safe when performed in a hospital setting.

7. sciencedirect.com sciencedirect.com/science/article/pii/S108112062201345X

Food Allergy P160 SINGLE VERSUS MULTI-ALLERGEN ... This retrospective study compares the safety and efficacy of multi-allergen versus single allergen oral immunotherapy (OIT) in two pediatric cohorts.

8. aaaai.org aaaai.org/tools-for-the-public/conditions-library/allergies/the-current-state-of-oral-immunotherapy

The Current State of Oral Immunotherapy Peanut, egg and milk OIT have been shown to desensitize approximately 60 to 80% of patients studied. Desensitization rates for other foods have not been as ...

9. roche.com roche.com/media/releases/med-cor-2025-03-02

Phase III study shows Xolair may be more effective with ... Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies · First- ...