Peanut AllergyIMPROVESNCT06256146
Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety
A study testing Food allergy desensitization / Oral Immunotherapy in people with Peanut Allergy and Milk Allergy, Cow's, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 40 years
- Conditions the study is for
- Peanut Allergy, Milk Allergy, Cow's, Egg Allergy
- What is being tested?
- Food allergy desensitization / Oral Immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 28 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.)
- Patients who present with intercurrent disease active at the time of starting desensitization.
- Non IgE mediated or non-immunological adverse reactions to milk or peanuts.
- Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
- Patients receiving oral immunosuppressor therapy.
- Patients receiving β-blockers (including topical formulations), or who receive daily doses of NSAIDs, aspirin or ACE inhibitors for cardiac issues.
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- Associated diseases contraindicating the use of epinephrine: cardiovascular disease, severe hypertension or hypotension.
- Patients diagnosed with eosinophilic gastrointestinal disorders, including patients with a history of antacid use for reflux related to food impaction or with a history of esophageal spasm.
- Patients already tolerating processed/cooked forms of the food (e.g.,baked goods with milk).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
Duncan Lejtenyi, MSc, 514-934-1934 ext. 22369, duncan.lejtenyi@muhc.mcgill.ca
Liane Beaudette, 514-934-1934 ext. 68264, liane.beaudette@muhc.mcgill.ca
About this study
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.
- Conditions
- Peanut Allergy, Milk Allergy, Cow's, Egg Allergy
- Being tested
- Food allergy desensitization / Oral Immunotherapy
- Medical subject headings
- Peanut Hypersensitivity, Milk Hypersensitivity, Egg Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food allergy desensitization / Oral ImmunotherapyOther
Participants consume increasing doses of allergenic food daily until they reach a maintenance dose. In the case of the High Dose Arm, participants will progress to a daily dose of either 1200 mg, 300 mg or 200 ml of egg, peanut or milk respectively.
Participants randomized to the Low Dose Arm also begin by consuming small amounts of the allergenic food, gradually increasing the daily dose. However, participants in this group only progress to 300 ml, 30 mg or 50 ml daily dose of egg, peanut or milk respectively.
The Cooked/Transformed Allergen Arm begins the desensitization with a cooked or transformed form of the allergen - muffins in the case of egg or milk, Bamba puffs in the case of peanut. Participants take increasing amounts of these products (one muffin for egg and milk and four Bamba puffs for peanut) then transition to egg, milk or peanut. Participants then continue their dose progression, getting to 1200 mg, 200 ml or 300 mg for egg, milk and peanut respectively.
| Study group | Role | What they receive |
|---|---|---|
| Standard Protocol - High Dose Arm | Experimental | 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. Receives: Other: Food allergy desensitization / Oral Immunotherapy |
| Modified Protocol - Low Dose Arm | Experimental | 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. Receives: Other: Food allergy desensitization / Oral Immunotherapy |
| Modified Protocol - Cooked/Transformed Allergen Arm | Experimental | 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. Receives: Other: Food allergy desensitization / Oral Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of anaphylaxis in different Oral Immunotherapy protocols
Do participants in the different study arms experience similar rates of anaphylaxis during their participation in the study? Anaphylaxis is defined as an allergic reaction to the food the subject is allergic to, that involves symptoms in two of the following organ systems: skin, respitratory, gastro-enterologic or neurologic.The Consortium for Food Allergy Research (CoFAR) grading scale will be used for assessing severuty of allergic symptoms
Measured: 3 years
Secondary outcomes (1)
Efficacy of different Oral Immunotherapy protocols
Do participants in the three study arms experience similar levels of desensitization to their allergen? This will be assessed by a Double-Blind Placebo Controlled Oral Food Challenge (DBPCFC). Doses of allergen that elicit symptoms strong enough to end the challenge will be compared between the three groups. Symptom severity will be graded using the CoFAR grading scale.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Mar 2022
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, United Arab Emirates University
- Responsible party
- Principal investigator, Moshe Ben-Shoshan, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Moshe Ben-Shoshan, MD, Principal investigator, MUHC-RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256146
- Sponsor's protocol ID
- 2022-8424
- Acronym
- IMPROVES
- Status last verified
- May 2026
- First submitted
- 6 Jul 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared. All participant data will remain strictly confidential
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety
- ClinicalTrials.gov ID
- NCT06256146
- Acronym / sponsor ID
- IMPROVES / 2022-8424
- Conditions
- Peanut Allergy, Milk Allergy, Cow's, Egg Allergy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, United Arab Emirates University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Protocol - High Dose Arm | Experimental | Other: Food allergy desensitization / Oral ImmunotherapySubjects will progress through desensitization to a high maintenance dose - 1200 mg of crushed peanut, 200 ml of milk or 1200 mg of egg powder. |
| Modified Protocol - Low Dose Arm | Experimental | Other: Food allergy desensitization / Oral ImmunotherapySubjects will progress through desensitization to a low maintenance dose - 120 mg of crushed peanut, 50 ml of milk or 300 mg of egg powder. |
| Modified Protocol - Cooked/Transformed Allergen Arm | Experimental | Other: Food allergy desensitization / Oral ImmunotherapySubjects 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. |
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (9 listed)
- Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.)
- Patients who present with intercurrent disease active at the time of starting desensitization.
- Non IgE mediated or non-immunological adverse reactions to milk or peanuts.
- Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
- Patients receiving oral immunosuppressor therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food allergy desensitization / Oral ImmunotherapyParticipants consume increasing doses of allergenic food daily until they reach a maintenance dose. In the case of the High Dose Arm, participants will progress to a daily dose of either 1200 mg, 300 mg or 200 ml of egg, peanut or milk respectively. Participants randomized to the Low Dose Arm also begin by consuming small amounts of the allergenic food, gradually increasing the daily dose. However, participants in this group only progress to 300 ml, 30 mg or 50 ml daily dose of egg, peanut or milk respectively. The Cooked/Transformed Allergen Arm begins the desensitization with a cooked or transformed form of the allergen - muffins in the case of egg or milk, Bamba puffs in the case of peanut. Participants take increasing amounts of these products (one muffin for egg and milk and four Bamba puffs for peanut) then transition to egg, milk or peanut. Participants then continue their dose progression, getting to 1200 mg, 200 ml or 300 mg for egg, milk and peanut respectively. | Other | Modified Protocol - Cooked/Transformed Allergen Arm, Modified Protocol - Low Dose Arm, Standard Protocol - High Dose Arm |
Primary outcome
Rate of anaphylaxis in different Oral Immunotherapy protocols
Time frame: 3 years
Do participants in the different study arms experience similar rates of anaphylaxis during their participation in the study? Anaphylaxis is defined as an allergic reaction to the food the subject is allergic to, that involves symptoms in two of the following organ systems: skin, respitratory, gastro-enterologic or neurologic.The Consortium for Food Allergy Research (CoFAR) grading scale will be used for assessing severuty of allergic symptoms
1 secondary outcome
Efficacy of different Oral Immunotherapy protocols
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. No IPD will be shared. All participant data will remain strictly confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moshe Ben-Shoshan, MD principal investigator
MUHC-RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food allergy desensitization / Oral Immunotherapy in people with Peanut Allergy and Milk Allergy, Cow's, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duncan Lejtenyi, M.Sc (1-514-934-1934 ext. 22369, duncan.lejtenyi@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of anaphylaxis in different Oral Immunotherapy protocols (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.