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Identification of B Regulatory Cells by Flow Cytometry

NCT06876506 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

  • Pollen Allergy
  • Venom Allergy

Interventions

DIAGNOSTIC_TEST

Venepuncture

Whole blood flow cytometry analysis of T-/B-lymphocyte subsets, regulatory B cells and regulatory T cells. Serological detection (immunoassay) of allergen-specific IgE and IgG4

DRUG

Allergen Specific Immunotherapy

Test group receiving venom allergen immunotherapy as part of standard and routine care pathway (treatment commencement NOT for study purposes, cohort selected of those who are routinely commencing treatment).

DRUG

Allergen Specific Immunotherapy

Test group receiving pollen allergen immunotherapy as part of standard and routine care pathway (treatment commencement NOT for study purposes, cohort selected of those who are routinely commencing treatment).

Sponsors & Collaborators

  • Health Education England, Wessex

    collaborator OTHER

  • University of Manchester

    collaborator OTHER

  • Hull University Teaching Hospitals NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Kristina Emsell-Needham, BSc, MSc · Hull University Teaching Hospitals NHS Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-04-28
Completion
2027-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06876506 on ClinicalTrials.gov