Sustained Unresponsiveness (SU) to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy (NCT07158619) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Sustained Unresponsiveness (SU) to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy
Poland39 participantsStarted 2025-09
Plain-language summary
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).
Who can participate
Age range
4 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Severe asthma
* Poorly controlled mild-to-moderate asthma, defined as:
* FEV1 \< 80% (below the 5th percentile),
* FEV1/FVC ratio \< 75% (below the 5th percentile),
* Hospitalization due to asthma exacerbation within the past 12 months
* Oral, sublingual, or subcutaneous immunotherapy for other allergens during the first year/season of therapy
* Eosinophilic gastrointestinal disorders
* Severe, recurrent episodes of anaphylaxis within the last 6 months
* Chronic illnesses requiring ongoing treatment, including:
* Cardiac conditions
* Epilepsy
* Metabolic disorders
* Diabetes mellitus
* Use of the following medications:
* Daily oral corticosteroid therapy \>1 month within the past 12 months
* At least two courses of oral corticosteroids (minimum duration of 7 days each) in the past 12 months
* One course of oral corticosteroids (minimum 7 days) within the past 3 months
* Biologic therapies
* Treatment with β-blockers, ACE inhibitors, or calcium channel blockers
* Pregnancy
* Lack of informed consent for participation
* Lack of cooperation from the patient
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sustained unresponsiveness determined by the outcome of the OFC
Timeframe: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).