Not Yet RecruitingNot Applicable

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

Poland39 participantsStarted 2025-08

Plain-language summary

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).

Who can participate

Age range

3 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: * 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. Exclusion criteria: * 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, * Severe, recurrent episodes of anaphylaxis within the last 6 months, * Chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes, * Taking medication: * oral, daily steroid therapy \>1 month in the past 12 months, * At least two courses of oral steroid therapy (at least 7 days) within the last 12 months, * One oral steroid therapy (min. 7 days) in the last 3 months, * biological treatment, * therapy with β-blockers, ACE-inhibitors, calcium channel inhibitors, * Pregnancy, * No consent to participate in the study, * Lack of cooperation from the patient. Well-controlled asthma, allergic rhinitis, atopic dermatitis are not considered exclusion criteria.

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

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).

Trial details

NCT IDNCT07107451

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Katarzyna Grzela, MD, PhD

+48 22 3179431 katarzyna.grzela@wum.edu.pl

View on ClinicalTrials.gov More Food Allergy in Children trials