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Immunotherapy

Standard Protocol - High Dose Arm for Egg Allergy (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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

IMPROVES Trial 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.Check my eligibility

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.See study design

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.

IMPROVES Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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.

IMPROVES Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of anaphylaxis in different Oral Immunotherapy protocols

Secondary outcome measures

Efficacy of different Oral Immunotherapy protocols

Side effects data

From 2012 Phase 2 & 3 trial • 4 Patients • NCT00090493

75%

DVT

75%

Staphyloccocal infections

25%

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY

IMPROVES 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenOTHER

690 Previous Clinical Trials

6,945,118 Total Patients Enrolled

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

447 Previous Clinical Trials

159,392 Total Patients Enrolled

Moshe Ben-Shoshan, MDPrincipal InvestigatorMUHC-RI

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this research study?

"Inclusion in this research demands a diagnosed food allergy and an age between 2 and 40 years. The study is open to enrollment for up to 360 eligible individuals."

Answered by AI

Is the recruitment of participants currently ongoing for this clinical trial?

"Per clinicaltrials.gov, this current research study is actively enrolling subjects. The trial was initially registered on March 1st, 2022 and most recently revised on February 9th, 2024."

Answered by AI

Is the enrollment criteria for this study limited to individuals below 30 years of age?

"Potential participants aged over 2 years and under the age of 40 are eligible for enrollment in this study."

Answered by AI

What is the upper limit for the number of individuals participating in this clinical investigation?

"Indeed, the details on clinicaltrials.gov imply that this investigation is actively seeking volunteers. The trial was first publicized on March 1st, 2022 and last revised on February 9th, 2024. They aim to enroll a total of 360 participants from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

Moshe Ben-Shoshan 2022. "Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06256146.

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