Testing B-regulatory Cells as a Marker for Allergen Immunotherapy Response
Official title: Identification and Quantitation of Human B Regulatory Cells Via Flow Cytometry and Their Potential Role as a Treatment Efficacy Biomarker in Allergen-specific Immunotherapy
Run by Hull University Teaching Hospitals NHS Trust · NCT06876506 · Data updated 2026-11-12
This study tests whether changes in blood B-regulatory cells can signal successful allergen immunotherapy in adults with pollen, dust mite, or insect venom allergies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Hull University Teaching Hospitals NHS Trust Government |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Hull, East Yorkshire) |
| Status | Recruiting |
| Started | January 21, 2026 |
| Main results expected | May 31, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT06876506 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older with physician-diagnosed IgE-mediated pollen, dust mite, or insect venom allergies who are starting or currently undergoing AIT.
✕Probably not a fit
Patients whose allergy type is not pollen, dust mite, or insect venom or who do not show a change in B-regulatory cells may not experience a measurable benefit from this biomarker approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects blood samples and tolerability data from adults receiving allergen immunotherapy (AIT) for pollen, dust mite, or insect venom allergies. Researchers measure B-regulatory cells and IL-10 production at multiple time points to see if their levels correlate with symptom control after re-exposure. Quality of life questionnaires are used to explore links between immune markers and allergic symptoms. The goal is to identify a potential biomarker that could indicate treatment effectiveness earlier in the course of therapy. The study is conducted at Hull Teaching Hospital NHS Trust with support from collaborating institutions.
Why it matters
Potential benefit: If successful, B-regulatory cell measurements could help clinicians gauge AIT effectiveness earlier and tailor treatment decisions.
How similar studies have gone: Previous work has explored immune cell changes during AIT, but this study investigates B-regulatory cells as a potential early biomarker, making its approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hull Teaching Hospital NHS Trust
Hull, East Yorkshire, United Kingdom Recruiting
Study contacts
- Principal investigator: Kristina Emsell-Needham, BSc, MSc — Hull University Teaching Hospitals NHS Trust
- Study coordinator: Kristina Emsell-Needham, BSc, MSc
- Email: Kristina.Emsell-Needham@nhs.net
- Phone: +441482607813
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.