Health TrialsbyHealthPanel

Tolerance in Beekeepers

ConditionBee Sting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Plymouth NHS Trust

About this trial

Beekeepers experience multiple bee stings each year. Many of these beekeepers (25-60%) become sensitized to bee venom through the production of specific antibodies that target the bee venom. Although these antibodies are important in the triggering of an allergic reaction only a small number of sensitised beekeepers go on to have an allergic reaction with symptoms away from the site of the sting. These reactions can be severe and are known as anaphylactic reactions.

The study investigates why some beekeepers develop severe allergic symptoms after bee stings while others do not.

This study will explore factors in the blood that protect sensitised individuals from having anaphylactic reactions - meaning that despite being sensitised they are tolerant and do not react to subsequent stings.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals naive to beekeeping (<2 previous bee stings, none in the last 24 months)

no history of anaphylaxis to stings. Group 2 inclusion criteria.

Beekeepers with > approximately 10 stings/year who have been beekeeping for >3 years.

No history of anaphylaxis to bee venom. Group 3 inclusion criteria

Disqualifiers

Unable to understand protocol/consent.

Unable to commit to follow up visits.

Participants with a known history of mastocytosis or under investigation for suspected mastocytosis.

Participants undergoing desensitisation treatment to bee venom before the first visit.

Trial population

Group 1 inclusion criteria. Individuals naive to beekeeping (\<2 previous bee stings, none in the last 24 months). No history of anaphylaxis to bee stings. Group 2 inclusion criteria. Beekeepers with \> approximately 10 stings/year who have been beekeeping for \>3 years. No history of anaphylaxis to bee stings. Group 3 inclusion criteria Beekeepers with diagnosis of anaphylaxis to bee venom in the last 12 months who are sensitised to bee venom (as evidenced by positive specific IgE and positive skin test to bee venom).

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • skin prick test

    Diagnostic test

    Skin prick test for bee venom

  • Blood tests

    Diagnostic test

    IgE/G and T cell tolerance studies

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Group 12 interventions
Group B: Group 22 interventions
Group C: Group 32 interventions

Trial outcomes

Primary outcomes

1

Cell comparison

(i) To compare the number of various cell (CD4+, CD8+ and Treg etc.) populations in the non-sensitised control population (NS), the sensitised but tolerant beekeepers (TB) and the allergic beekeeper (AB) population.

Time frame
3 years
2

Cellular function

(ii) To identify differences in cellular function in the non-sensitised control population (NS), the sensitised but tolerant beekeepers (TB) and the allergic beekeeper (AB) population.

Time frame
3 years
3

Molecular mechanism

(iii) To elucidate the molecular mechanism and the differences observed in (i) and (ii).

Time frame
3 years
4

Epi regulation

(iiii) To elucidate the epigenetic regulation underpinning and the differences observed in (i) and (ii)

Time frame
3 years

Secondary outcomes

1

Sensitisation data- skin prick testing

To compare results of skin prick testing from the beginning and end of the beekeeping season.

Time frame
3 years
2

Sensitisation data - specific IgE's in blood

To compare results of specific IgE's in blood from the beginning and end of the beekeeping season.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Plymouth NHS Trust

Lead sponsor

University of Plymouth

Collaborator

Source ClinicalTrials.gov
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