Identification of B Regulatory Cells by Flow Cytometry (NCT06876506) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Identification of B Regulatory Cells by Flow Cytometry
United Kingdom80 participantsStarted 2026-08-01
Plain-language summary
The goal of this laboratory and observational study is to develop a test to quantify B-regulatory cells in blood. This will be used to detect changes in B-regulatory cell populations in pollen and insect venom allergic patients who are receiving routine allergen immunotherapy treatment. The primary question this study aims to answer is;
1). Are changes in blood B-regulatory cells associated with successful allergen immunotherapy treatment, and therefore do these changes suggest patients have developed a suitable level of allergen tolerance and reduction in their allergic symptoms upon re-exposure to the causal allergen.
Patients will also be asked to complete quality of life questionnaire periodically throughout the study to determine if there are associations between variation in B-regulatory cell populations in blood and allergic symptoms experienced.
Who can participate
Age range
18 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.
Control cohort - Participants with:
* No clinical and laboratory findings of IgE-mediated hypersensitivity (i.e. no clinical history of specific allergies to pollens, house dust mite or insect venoms
* Negative serological testing for specific IgE to pollens, house dust mite and insect venoms
* Patients aged 18 years or older
Test cohort:
* Participants over the age of 18 years
* Participants with physician-diagnosed IgE-mediated allergic disease to pollens, house dust mite or insect venoms
Exclusion Criteria:
* Patients under the age of 18 years
* Samples from patients with IgE-mediated allergic disease, treated or untreated, specific to allergens other than pollens, house dust mite and insect venom
* Participants who are pregnant
* Participants who cannot adequately understand verbal and / or written explanations given in English
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
Utility of B regulatory cells as a biomarker of AIT treatment sucess
Timeframe: From enrolment to 1 year post commencing allergen-specific immunotherapy treatment
Trial details
NCT IDNCT06876506
SponsorHull University Teaching Hospitals NHS Trust