Hemp Seed Awareness

NCT04841954 | Recruiting

• 1 other identifier: 49RC21_0048
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

• Positive prick-test

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

  Day 1

Secondary Outcomes (1)

• history of hemp use

  Day 1

Study Arms (1)

Prick-test

EXPERIMENTAL

Diagnostic Test: hemp prick-test

Interventions

hemp prick-test DIAGNOSTIC_TEST

hemp seed and flower prick-test

Prick-test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

MORISSET Martine

Angers, France

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Martine MORISSET

CONTACT

0241353637; martine.morisset@chu-angers.fr

DRCI Promotion Interne

CONTACT

0241353637; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 12, 2021
• Study Start: June 1, 2021
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

FR (1)