Oral Immunotherapy for Food Allergies
(IMPROVES Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Must not be taking: Immunosuppressors, Beta-blockers, NSAIDs, others
Disqualifiers: Uncontrolled respiratory disease, Cardiovascular disease, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Protocols for Oral Immunotherapy (OIT) for the main food allergens have been recently incorporated in clinical practice for food allergies and their clinical benefits have been acknowledged in European and Canadian official guidelines. There has been some reluctance in both clinicians and patients to implement these therapies, primarily because of the risk of allergic reactions during the desensitization process. This study will investigate if protocols using low doses of a food allergen or processed versions of the allergen can be both effective in conferring desensitization while inducing fewer allergic symptoms during the desensitization process.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as oral immunosuppressors, β-blockers, NSAIDs, aspirin, and ACE inhibitors. If you are on any of these, you would need to stop them to participate.
What data supports the effectiveness of this treatment for food allergies?
Research shows that oral immunotherapy (OIT) can help desensitize people with food allergies, allowing them to tolerate small amounts of the allergen. However, the benefits may decrease if the treatment is stopped, and there can be side effects.
12345Is oral immunotherapy generally safe for humans?
Oral immunotherapy (OIT) for food allergies can cause adverse reactions, including serious ones like anaphylaxis (a severe allergic reaction). Safety concerns are a major barrier to its widespread use, and more consistent safety data is needed to better understand and manage these risks.
678910How is the Modified Oral Immunotherapy treatment different from other treatments for food allergies?
Modified Oral Immunotherapy (OIT) is unique because it involves gradually introducing small amounts of the allergenic food to the patient to help their immune system tolerate it, unlike other treatments that mainly focus on avoiding the allergen. This approach aims to increase the threshold for allergic reactions, potentially reducing the risk of severe reactions from accidental exposure.
16111213Eligibility Criteria
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.Inclusion Criteria
I have had a severe or moderate allergic reaction to a specific food within 2 hours of eating it.
I have a confirmed food allergy through skin or blood tests.
Exclusion Criteria
I am currently taking oral medication to suppress my immune system.
I take β-blockers, NSAIDs, aspirin, or ACE inhibitors daily for heart problems.
Non IgE mediated or non-immunological adverse reactions to milk or peanuts
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Desensitization
Participants undergo oral immunotherapy with low doses or processed versions of allergens to achieve desensitization
Varies by protocol
Maintenance
Participants maintain a stable dose of allergen to sustain desensitization
Up to 3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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.
Modified Oral Immunotherapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Palforzia for:
- Peanut allergy
🇪🇺 Approved in European Union as Oral Immunotherapy for:
- Peanut allergy
- Egg allergy
- Milk allergy
- Other food allergies
🇨🇦 Approved in Canada as Oral Immunotherapy for:
- Peanut allergy
- Other food allergies (research settings)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research Institute of the McGill University Health CentreMontreal, Canada
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Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
The Hospital for Sick ChildrenCollaborator
References
CSACI guidelines for the ethical, evidence-based and patient-oriented clinical practice of oral immunotherapy in IgE-mediated food allergy. [2022]Oral immunotherapy (OIT) is an emerging approach to the treatment of patients with IgE-mediated food allergy and is in the process of transitioning to clinical practice.
Immunologic changes during desensitization with cow's milk: How it differs from natural tolerance or nonallergic state? [2022]Oral immunotherapy (OIT) is a novel allergen-specific treatment for food allergies.
Oral Immunotherapy for Egg Allergy: A Double-Blind Placebo-Controlled Study, with Postdesensitization Follow-Up. [2015]Oral immunotherapy (OIT) may be an effective treatment for food allergy in children. It is not clear if the OIT-induced effect is achieved by desensitization (transient state dependent on regular antigen exposure), or by tolerance (persistent condition where the ability to consume the food is retained even after a period of withdrawal).
Immune mechanisms of oral immunotherapy. [2020]Oral immunotherapy (OIT) has demonstrated reproducibly successful desensitization in patients with food allergy completing clinical trials and, in some studies, sustained unresponsiveness. These clinical outcomes have been associated with characteristic modifications in the allergen-specific immune response, but a detailed synthesis of OIT's mechanisms of action is lacking. In this rostrum we review the current evidence regarding the human immune response to OIT, explore possible mechanisms, and identify knowledge gaps for future research.
A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy. [2022]Although studies of oral immunotherapy (OIT) for food allergy have shown promise, treatment is frequently complicated by adverse reactions and, even when successful, has limited long-term efficacy because benefits usually diminish when treatment is discontinued.
Safety profile of oral immunotherapy with cow's milk and hen egg: A 10-year experience in controlled trials. [2017]Oral immunotherapy (OIT) for food allergy is gaining interest due to the favorable clinical results reported with cow's milk, hen egg and peanut. The safety of the procedure remains a critical aspect that can limit the introduction of OIT in clinical practice.
Safety of Food Oral Immunotherapy: What We Know, and What We Need to Learn. [2020]Oral immunotherapy (OIT) for food allergy entails a risk of adverse reactions, including anaphylaxis. This safety concern is the major barrier for OIT to become a therapeutic option in clinical practice. The high heterogeneity in safety reporting of OIT studies prevents setting the safety profile accurately. An international consensus is needed to facilitate the analysis of large pooled clinical data with homogeneous safety reporting, that together with integrated omics, and patients/families' opinions, may help stratify the patients' risk and needs, and help developing safe(r) individualized care pathways. This will give OIT the right place in the food allergy therapy.
Effect of ketotifen premedication on adverse reactions during peanut oral immunotherapy. [2022]Oral immunotherapy (OIT) has shown promise in inducing desensitization for food allergy. However, there are safety concerns regarding the frequency and severity of adverse events during food OIT.
Comparing the risk of anaphylaxis requiring epinephrine in oral immunotherapy and subcutaneous immunotherapy: A review of recent Canadian real-world literature. [2023]The safety of pediatric food oral immunotherapy (Ped-OIT) has been depicted by some as less favorable than subcutaneous immunotherapy (SCIT) owing to the increased number of serious adverse events requiring epinephrine. A review of real-world data comparing Ped-OIT and SCIT safety is necessary to guide shared decision making.
Phase 2, randomized multi oral immunotherapy with omalizumab 'real life' study. [2022]Oral immunotherapy (OIT) is frequently discontinued due to adverse events (AEs) and current data suggests that lowering OIT doses can minimize severity and frequency of AEs. However, the minimum daily dose that can enable desensitization and induce immune responses in multi-food OIT (mOIT) is unknown.
Oral Immunotherapy for Treatment of Immunoglobulin E-Mediated Food Allergy: The Transition to Clinical Practice. [2022]Today, there is neither an effective nor an active treatment for food allergy. Allergy immunotherapy has been proposed as an attractive strategy to actively treat food allergy. Oral immunotherapy (OIT), also known as oral desensitization, is a method of inducing the body's immune system to tolerate a food that causes an allergic overreaction. It has been studied for the use in treatment of immunoglobulin E-mediated food allergy to the most common foods, including milk, egg, and peanut. OIT has been able to desensitize subjects to varying degrees. However, many questions remain unanswered, including efficient formulation, optimal dosing, and induction protocol to achieve full tolerance, transition of OIT to clinical practice, and maximal safety profile. This review focuses on the use of OIT as a new and active treatment for food allergy. The possibility of transition of OIT to clinical practice represents, in this field, the next pivotal step with the goal of improving the quality of life of patients with food allergy and their families.
Safety of Multifood Oral Immunotherapy in Children Aged 1 to 18 Years at an Academic Pediatric Clinic. [2023]Oral immunotherapy (OIT) aims to increase the reaction threshold to a food allergen and decrease the risk of a potentially life-threatening allergic reaction in the event of an accidental ingestion. Whereas single-food OIT is the most extensively studied, data on multifood OIT are limited.
Oral immunotherapy in alpha-gal red meat allergy: Could specific IgE be a potential biomarker in monitoring management? [2023]Oral immunotherapy (OIT) is a promising treatment for food allergies. Our aim was to establish the long-term safety and efficacy of a novel red meat (RM) OIT in galactose-alpha-1,3-galactose (alpha-gal) allergy in adults.