About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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,
Trial design
Treatments tested in this trial
- OIT with low dose sesame protein