Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy

Study Overview
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Brief Summary
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This is an experimental, interventional study, following on from a clinical trial comparing the efficacy and safety of oral immunotherapy with low and high doses of sesame protein, in which patient desensitisation was achieved (High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety, NCT05158413). The aim of this study is to assess a sustained unresponsiveness (SU) to sesame protein after at least 8 months of previously assigned high- or low-dose sesame OIT, followed by 4-week-allergen avoidance, and verified by an open oral food challenge (OOFC).

Detailed Description
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Oral immunotherapy is considered the most effective treatment for food allergy. There are two main goals of food immunotherapy: achievement of desensitisation and sustained unresponsiveness. Desensitisation involves achieving temporary tolerance of the allergenic food by the patient only during regular intake of the allergen. The most desirable effect of immunotherapy is to achieve sustained unresponsiveness, i.e. to maintain the absence of adverse symptoms to a given allergen after specific immunotherapy has been discontinued for a defined period of time. The study is a continuation of a clinical trial NCT05158413 which was designed to compare the efficacy and safety of oral immunotherapy (OIT) with low or high doses of sesame protein (300 or 1200 mg, respectively) in children with a confirmed diagnosis of sesame allergy. The participants of current study will be recruited from patients who have accomplished their per-protocol participation in previous trial. Patients will receive the same maintenance dose of sesame allergen, which was used in previous trial (300 or 1200 mg, respectively), for 32 weeks (+/-2 weeks). Then, OIT will be discontinued for 4 weeks with strict sesame avoidance. Subsequently, an open oral food challenge (OOFC) will be performed to assess the achievement of sustained unresponsiveness.

Official Title
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Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy - Evaluation of Efficacy and Safety

Conditions
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Food Allergy

Intervention / Treatment
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* Dietary Supplement: High dose OIT
* Dietary Supplement: Low dose OIT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who have accomplished their per-protocol participation in trial NCT05158413. signed Informed Consent by parent/legal guardian and patient aged>16 years old patient's/caregiver's cooperation with researcher Exclusion Criteria: severe asthma uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5 percentile), FEV1/forced vital capacity (FEV)<75% (under 5 percentile), hospitalization due to asthma exacerbation within last 12 months current oral/sublingual/subcutaneous immunotherapy with another allergen eosinophilic esophagitis allergic reaction of 4th or higher grade according to the World Allergy Organisation Systemic Allergic Reaction Grading System during immunotherapy a history of severe recurrent anaphylaxis episodes chronic diseases requiring continous treatment, including heart disease, epilepsy, metabolic disease, diabetes medication: oral, daily steroid therapy exceeding 1 month within the last 12 months at least two courses of oral steroid therapy (at least 7 days) within the last 12 months oral steroid therapy longer than 7 days within the last 3 months biological treatment the need to constantly take antihistamines therapy with b-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors pregnancy no consent to participate in the study lack of patient cooperation

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose<br>20 patients Intervention: Dietary Supplement: High dose OIT | Dietary Supplement: High dose OIT<br>* Patients will receive daily a high dose of the sesame paste (1200 mg sesame protein) mixed with well-tolerated fruit mousse or bread.<br>|
| Active Comparator: Low dose<br>20 patients Intervention: Dietary Supplement: Low dose OIT | Dietary Supplement: Low dose OIT<br>* Patients will receive daily a low dose of the sesame paste (300 mg sesame protein) mixed with well-tolerated fruit mousse or bread.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained unresponsiveness to a sesame protein after discontinuing oral immunotherapy for 4 weeks. | Percentage of patients tolerating their maintenance dose of sesame protein after a 4-week break in immunotherapy | Up to 9 months after starting maintenance phase | 
| The highest tolerated dose of sesame protein after discontinuing oral immunotherapy for 4 weeks. | Sustained unresponsiveness assessed as the highest tolerated dose of sesame protein at oral food challenge. | Up to 9 months after starting maintenance phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number and severity of adverse events during OIT treatment and at OOFC will be assessed and compared between both groups. | Up to 9 months after starting maintenance phase | 
| Laboratory data | Change in sesame serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level at different time points: before immunotherapy, at the end of the maintenance phase and after a 4-week break in immunotherapy, assessed for each individual and compared between groups. | Up to 9 months after starting maintenance phase | 
| Skin prick test (SPT) | Difference in wheal diameter in skin prick tests (SPT) assessed between groups at the respective time points: before immunotherapy, at the end of the maintenance phase and after a 4-week break in immunotherapy. | Up to 9 months after starting maintenance phase | 
| Tolerance of a single dose of 4000 mg of sesame protein | Percentage of patients tolerating a single dose of 4000 mg of sesame protein after a 4- week break in immunotherapy. | Up to 9 months after starting maintenance phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sesame, food allergy, sustained unresponsiveness, children