What side effects are associated with this type of intervention?

Oral Immunotherapy (OIT) for food allergies, which involves the gradual desensitization to allergens, is associated with several side effects. Common adverse events include mild to moderate symptoms such as oropharyngeal pruritus (itchiness in the mouth and throat), gastrointestinal discomfort, and skin reactions. More serious side effects can include anaphylaxis, which may require treatment with epinephrine. Additionally, there is a risk of developing eosinophilic esophagitis (EoE), a chronic immune system disease. The rate of adverse events tends to be higher during the initial phases of treatment and can lead to a significant dropout rate among participants.

What prior FDA approvals exist?

The FDA has approved treatments for food allergies that include oral immunotherapy (OIT) and monoclonal antibodies like omalizumab. OIT involves the gradual introduction of small amounts of the allergen to build tolerance, while omalizumab is used to facilitate rapid desensitization and reduce allergic reactions. These treatments aim to increase the threshold of allergen tolerance and provide protection against accidental exposures.

What other types of research exist?

Promising novel alternatives to Oral Immunotherapy (OIT) for food allergy patients in 2024 include: 1) Sublingual Immunotherapy (SLIT), which has shown efficacy in desensitizing patients with fewer systemic reactions compared to OIT. 2) Epicutaneous Immunotherapy (EPIT), which involves applying allergen patches to the skin and has demonstrated safety and effectiveness, particularly for peanut and cow's milk allergies. 3) Combination therapies, such as OIT combined with anti-IgE treatments like omalizumab, which can reduce the risk of severe allergic reactions and allow for more rapid desensitization. These alternatives offer different approaches to managing food allergies with varying degrees of invasiveness and side effect profiles.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 18

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

0 / 7Eligibility criteria met

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.