ARCHANGE: Hemp Seed Awareness

Sponsor
University Hospital, Angers (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04841954
Collaborator
(none)
600
1
18

Study Details

Study Description

Brief Summary

Hemp is a plant of the Cannabaceae family. Cannabis sativa, derived from female flowers, is the first illicit substance used by adolescents and is a major public health problem. Its psycho-active effects come from tetrahydrocannabinol (THC).

Unlike recreational cannabis, industrial hemp derived from cannabis sativa has a high level of cannabidiol (CBD) but a negligible level of tetrahydrocannabinol. Its seeds are now consumed in various forms and generate increasing interest. Seeds have many nutritional benefits.

It seems important to take an interest in hemp, given the recent expansion of medical cannabis and the increasing use of cannabis for recreational purposes. It is incriminated in various allergies (contact dermatitis, asthma, rhinoconjunctivitis) but also in the occurrence of anaphylaxis to certain foods by cross-allergy in atopic subjects, in association with an Lipid-Transfer Proteins (LTP protein), present in the flower of Cannabis sativa.

Unlike the allergy to recreational cannabis, the allergenicity of hemp seeds is little studied.

Hemp seed can cause severe anaphylactic reactions. In all reported cases, the prick-tests were positive for the seeds. Often, patients had never been in contact with hemp seeds but had already been exposed to cannabis by respiratory or manual routes.

The investigators hypothesize that sensitization by the skin or respiratory route (cannabis smokers, passive exposure to cannabis, workers exposed to hemp, etc.) could lead to the development of a food allergy to hemp seed.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: hemp prick-test
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Hemp Seed Awareness
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prick-test

Diagnostic Test: hemp prick-test
hemp seed and flower prick-test

Outcome Measures

Primary Outcome Measures

  1. Positive prick-test [Day 1]

    To assess the prevalence of hemp seed sensitization in the allergy consulting population

Secondary Outcome Measures

  1. history of hemp use [Day 1]

    To study the association between sensitization to hemp seed and patient characteristics

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Major patient

  • Patient referred to the Allergology Unit of the Hospital of Angers, in consultation or in Hospitalization - for conducting prick-tests

  • Patient affiliated or beneficiary of a social security scheme

  • Patient with informed consent

Exclusion Criteria:
  • Pregnant women, parturients

  • Persons deprived of liberty by administrative or judicial decision

  • Persons receiving psychiatric care under duress

  • Adults under legal protection measure

  • People out of state to express consent

  • people not able to understand French language

  • Patients whose skin reactivity prevents interpretation of tests (patients who cannot interrupt anti-histamines or have severe eczema)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT04841954
Other Study ID Numbers:
  • 49RC21_0048
First Posted:
Apr 12, 2021
Last Update Posted:
Apr 12, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 12, 2021