Sustained Unresponsiveness (SU) to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorMedical University of Warsaw

About this trial

This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial in the Pediatric Population", NCT06328504. 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 cashew nut protein (1200mg) for the next 8 months (+/- 3 weeks). * Second arm (initial control group - one year on a cashew nut 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

Cashew nut allergy confirmed prior to the initiation of immunotherapy

Completion of the first phase of the study, including achievement of the maintenance dose (1200 mg of cashew nut protein) during immunotherapy

Provision of informed consent for participation in the study

Adequate cooperation from the patient and/or their legal guardians

Disqualifiers

Severe asthma

FEV1 < 80% (below the 5th percentile),

FEV1/FVC ratio < 75% (below the 5th percentile),

Hospitalization due to asthma exacerbation within the past 12 months

Trial design

Treatments tested in this trial

  • OIT with cashew nut protein

Treatment groups

39 Participants
are divided into 2 treatment groups

Sponsors and collaborators