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Immunotherapy

Oral Immunotherapy for Food Allergies (IMPROVES Trial)

N/A

Recruiting

Led By Moshe Ben-Shoshan, MD

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A history suggestive of immediate allergy to the food. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact

The presence of at least one of the following confirmatory tests: Positive SPT to the culprit food allergen (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of the foods (Omega Labs, Toronto, Ontario). Detection of serum specific IgE (>0.35 kU/L) to the culprit food or any of its proteins, measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden)

Must not have

Patients receiving oral immunosuppressor therapy

Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if using low doses of a food allergen or processed versions of the allergen can help reduce allergic reactions during oral immunotherapy for food allergies. The goal is to make the treatment

Who is the study for?

This trial is for individuals with food allergies. Participants should be willing to undergo Oral Immunotherapy (OIT), which involves consuming small amounts of the allergen. The study aims to include those who are open to trying new desensitization protocols.

What is being tested?

The study tests modified Oral Immunotherapy protocols using either low doses or processed versions of food allergens, aiming to reduce allergic reactions during treatment and still effectively desensitize patients against their food allergies.

What are the potential side effects?

Potential side effects may include allergic symptoms such as itching, swelling, gastrointestinal discomfort, or more severe reactions like anaphylaxis during the desensitization process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a severe or moderate allergic reaction to a specific food within 2 hours of eating it.

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I have a confirmed food allergy through skin or blood tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking oral medication to suppress my immune system.

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I have a respiratory condition like asthma that is not well-managed.

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I have an active illness as I start desensitization treatment.

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I have a severe immune system disorder.

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I do not have heart disease, severe high or low blood pressure.

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I have been diagnosed with an eosinophilic gastrointestinal disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of anaphylaxis in different Oral Immunotherapy protocols

Secondary study objectives

Efficacy of different Oral Immunotherapy protocols

Side effects data

From 2023 Phase 3 trial • 1460 Patients • NCT04145219

58%

Oral pruritus

55%

Throat irritation

33%

Ear pruritus

33%

Abdominal pain upper

25%

Nasopharyngitis

21%

Lip swelling

20%

Glossodynia

19%

Nausea

17%

Taste disorder

14%

Mouth swelling

14%

Swollen tongue

13%

Mouth ulceration

13%

Diarrhoea

Pharyngeal swelling

Vomiting

Tongue ulceration

Tooth loss

Bronchitis

COVID-19

Pharyngitis

Upper respiratory tract infection

Asthma

100%

80%

60%

40%

20%

Study treatment Arm

HDM SLIT-tablet (12 SQ-HDM)

Placebo SLIT-tablet

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Standard Protocol - High Dose ArmExperimental Treatment1 Intervention

Subjects will progress through desensitization to a high maintenance dose - 1200 mg of crushed peanut, 200 ml of milk or 1200 mg of egg powder.

Group II: Modified Protocol - Low Dose ArmExperimental Treatment1 Intervention

Subjects will progress through desensitization to a low maintenance dose - 120 mg of crushed peanut, 50 ml of milk or 300 mg of egg powder.

Group III: Modified Protocol - Cooked/Transformed Allergen ArmExperimental Treatment1 Intervention

Subjects will begin desensitization with cooked versions of the allergen (muffins in the case of egg and milk) or transformed versions (Bamba puffs for peanut). They will progress up to a full muffin or 4 Bamba puffs (for egg/milk and peanut respectively). Once subjects have reached these doses, they will transition to doses of pure allergen. They will then progress to the same top dose as subjects in the High Dose Arm.

0 / 8Eligibility criteria met