A Phase 2 interventional study of multi-OIT in Food Allergy, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by The Hospital for Sick Children · Phase 2, Interventional, and Treatment
Oral immunotherapy (OIT) is a food allergy treatment where small amounts of the food a child is allergic to is eaten and gradually increased over time with the aim to be able to eat a certain amount of the allergen without experiencing an allergic reaction. While this process works in many children there are concerns about safety, feasibility and drop-outs and how to adapt protocols for multiple allergies.
Many OIT trials have targeted approximately 4000mg of single food/day. In these trials up to 40% drop-out. There is evidence much lower doses can have beneficial effects.
The investigators will evaluate if low doses of foods can allow for OIT to multiple foods. This approach may have efficacy against accidental exposure and be able to demonstrate immune changes. This approach may have a low burden of treatment and a low rate of allergic reactions and
This is a single-arm, open label, study of the intervention of low dose multiple-nut OIT in nut allergic children.
After meeting eligibility criteria, participants will have a food challenge to 2-5 nuts.
If the oral food challenge is positive, participants will be enrolled in the study to multiple nut OIT. A blood draw and quality of life (QOL) survey will occur at baseline.
Participants will have dose escalation visits of the multiple nut OIT every 2 months to a target dose of 30mg of each nut protein. A blood draw and QOL survey will occur at 6 months.
Participants will then continue with daily ingestion of the 30mg of each nut protein for 1 year with visits every 3 months.
After 18 months from the start of the study, another oral food challenge will be given to participants to assess the change in the maximum tolerated dose of nuts. A blood draw will assess changes in the immune parameters. A QOL survey will occur at 18 months to assess changes in QOL.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 18 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low dose OIT with multiple allergens
Other: multi-OIT
low dose OIT to multiple foods
Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner
Change in how much nuts the participant can eat without an allergic reaction after the low dose OIT assessed as dichotomous did the participant reach 5 times the baseline eliciting dose
Time frame: month 0, month 18
Immunological change in IgG4
Change in allergen specific immunoglobulin G4 (IgG4) from baseline to end
Time frame: month 0, month 18
Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale
A continuous variable amount tolerated at baseline vs at end
Time frame: month 0, month 18
Immunological change in IgG4
Change in IgG4 from measures from historical data to 18 month of study. Some patients will have historical IgG4 values to compare
Time frame: pre-study, month 18
Desensitization to allergic food as assessed by maximum tolerated dose
Did they reach 300mg (cumulative) on the 18 month exit oral food challenge
Time frame: month 18
Desensitization to allergic food as assessed by maximum tolerated dose
Did they reach 140mg (cumulative) on the 18 month exit oral food challenge
Time frame: month 0, month 18
Feasibility analysis as assessed by can the patients achieve the maintenance dosing of the allergen mix for OIT
Proportion who achieve maintenance doses of their allergen mix (descriptive)
Time frame: month 18
Feasibility analysis as assessed by drop-out rate
Proportion who drop-out of the study (descriptive)
Time frame: month 18
Incidence of Treatment-Emergent Adverse Events: Safety analysis as assessed by use of epinephrine
Administration of epinephrine; (descriptive);
Time frame: month 18
Quality of life scale
Change in quality of life at 18m of children compared to baseline assessment (using validated questionnaire: Food allergy quality of life questionnaires (FAQLQ) FAQLQ Parental form (PF) for ages 0-12 OR the FAQLQ-teenager form (TF) using total score. The FAQLQ total and domain scores range from 1-7 with higher scores indicative of worse health related quality of life with the total score being the average of the domain scores. The domains include Emotional Impact, Social and Dietary Restrictions, Food Anxiety, Allergen Avoidance, and Risk of Accidental Exposure.
Time frame: month 0, month 18
Change in allergen specific IgE, and components
Change in allergen specific IgE, and components via microarray
Time frame: month 0, month 18
Basophil activation test
Basophil activation test
Time frame: month 0, month 18
Skin prick test (SPT) reactivity to the individual nut extracts
The size of the skin prick test will be compared
Time frame: month 0, month 18
High content functional immune profiling via mass cytometry and single cell sorting
Compare the change in the immune pattern
Time frame: pre-study, month 18
Number of participants with treatment related adverse effects
Diaries will be analyzed for allergic symptoms and tabulated
Time frame: month 0, month 18
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Hospital for Sick Children