This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project:
* First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with low dose of sesame protein (300mg) for the next 8 months (+/- 3 weeks). * Second arm (initial control group - one year on a sesame elimination diet) - patients will begin OIT following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months (+/- 3 weeks).
After an additional 8 months (+/- 3 weeks) of OIT, all study participants will undergo a 4-week cessation of treatment, followed by an open Oral Food Challenge (OFC) to assess the development of sustained unresponsiveness (SU).
Sesame allergy confirmed before starting immunotherapy
Completion of the first part of the study - achieving the maintenance dose (300mg sesame protein) during immunotherapy
Obtaining informed consent to participate in the study,
Patient/carer cooperation.
Severe asthma,
Mild/moderate poorly controlled asthma: FEV1<80% (under 5. percentile), FEV1/FVC<75% (under 5. percentile), hospitalisation for asthma exacerbation in the last 12 months,
Oral/sublingual/subcutaneous immunotherapy against other allergens in the first year/season of immunotherapy
Eosinophilic gastroenteritis,
Parallel
OIT with low dose sesame protein
Dietary supplementAfter 8 months of continued low-dose sesame OIT, patients will undergo hospital-based assessments, including skin prick testing, laboratory evaluations, and an open Oral Food Challenge (OFC) to evaluate desensitization. Patients who had a negative OFC after 3 months in the initial phase of the study-and thus confirmed desensitization-will skip the pre-break OFC and proceed directly to the next stage. Following a 4-week interruption in OIT, patients will return for a final hospital visit, during which a concluding OFC will be conducted to assess sustained unresponsiveness. Additional laboratory tests and skin prick testing will also be performed at this visit.
Sustained unresponsiveness determined by the outcome of the OFC
Percentage of patients achieving sustained unresponsiveness after low-dose (300 mg) sesame oral immunotherapy, defined as tolerating 4 g of sesame in OFC after 4 weeks of sesame avoidance.
Changes in sesame protein tolerance during OFC
Comparison of the amount of sesame protein tolerated during each oral food challenge (OFC) by each patient. Every OFC will be performed according to PRACTALL guidelines.
Adverse event
Quantity and severity of adverse effect divided into 3 categories: mild, moderate and severe reactions.
Quality of life - FAQLQ (Food Allergy Quality of Life Questionnaire)
Assessment of the quality of life of patients and their families before each open oral sesame protein challenge trial (impact of allergy on family life) based on the Food Allergy Quality of Life Questionnaire (FAQLQ). Based on the FAQLQ score, quality of life will be assessed on a scale ranging from minimal to severe impairment due to food allergy.
Basophil activation test (BAT)
Assessment of CD63+ basophil marker expression prior to desensitisation and before any OFC.
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