Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Allergen-specific Immunotherapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorMedical University of Warsaw

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

Treatment groups

39 Participants
are divided into 2 treatment groups

Sponsors and collaborators