Hemp Seed Awareness (ARCHANGE)

June 10, 2024 updated by: University Hospital, Angers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prick-test
Diagnostic test: hemp prick-test
hemp seed and flower prick-test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive prick-test
Time Frame: Day 1
To assess the prevalence of hemp seed sensitization in the allergy consulting population
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
history of hemp use
Time Frame: Day 1
To study the association between sensitization to hemp seed and patient characteristics
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

April 9, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 49RC21_0048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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