blood sample and skin prick tests
Diagnostic TestBlood sample and skin prick tests in addition to the blood tests and skin prick tests originally scheduled for the patient's care
NCT Number: NCT07652853
Cannabis sativa is an annual herbaceous plant from the Cannabaceae family that has been cultivated and consumed by humans for thousands of years. Its main uses include fiber production, seeds for human and animal food, and psychoactive medications. Indeed, cannabis is the most commonly consumed illicit substance among adolescents and poses a major public health issue. Allergic risks associated with cannabis have already been documented.
At the same time, the consumption of hemp seeds is increasing due to the current agro-food context and the rise of vegan and vegetarian diets. This new food raises questions about its potential allergic risks, especially since the prevalence and severity of food allergies have been steadily increasing over the years. In this context, cases of anaphylaxis related to hemp seeds have already been reported. However, the potential allergic risk associated with hemp seeds remains largely unstudied to date.
Several reasons make research into hemp seed allergies relevant:
i) increased exposure to Cannabis sativa in its various forms, with the possibility of finding identical or similar proteins in the seeds; ii) changes in dietary habits, with the vegan trend encouraging the consumption of many seeds, including hemp seeds.
Trial opening soon.
Get Notified2 year and older
All sexes
Interventional
Not applicable
All study-specific examinations are performed during the enrollment visit, which takes place during a routine medical visit
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
i) Individuals with known or suspected cannabis allergy: Allergy or suspected allergy to hemp seed (HS) defined by A suggestive clinical history of HS allergy and Positive skin prick test (SPT) to HS (≥ 6 mm with erythema exceeding the control papule) and/or Basophil activation test (BAT) confirming HS allergy diagnosis OR Allergy or suspected allergy to hemp flower (female or male) defined by a suggestive clinical history of hemp allergy and positive SPT to hemp flower (≥ 6 mm with erythema) and/or ImmunoCAP IgE to hemp > 0.35 KU/L ii) Individuals allergic to tree nuts (hazelnut or walnut): Allergy to walnut defined by a suggestive clinical history of IgE-mediated walnut allergy and positive SPT to walnut (≥ 8 mm) and IgE to Jug r 1, Jug r 2, or Jug r 3 > 1 KU/L and/or BAT confirming walnut allergy diagnosis OR Allergy to hazelnut defined by a suggestive clinical history of IgE-mediated hazelnut allergy and positive SPT to hazelnut (≥ 8 mm) and IgE to Cor a 9, Cor a 11, Cor a 14, or Cor a 8 > 1 KU/L and/or BAT confirming hazelnut allergy diagnosis iii) Individuals allergic to seeds (sesame, flax, pumpkin, sunflower): Allergy to sesame defined by a suggestive clinical history of IgE-mediated sesame allergy and positive SPT to sesame (≥ 6 mm) and/or IgE to sesame and/or molecular components (Ses i 1 to Ses i 7) > 0.35 KU/L and/or BAT confirming sesame allergy diagnosis OR Allergy to flaxseed defined by a suggestive clinical history of IgE-mediated flaxseed allergy and positive SPT to flaxseed (≥ 6 mm) and/or IgE to flaxseed > 0.35 KU/L and/or BAT confirming flaxseed allergy diagnosis OR Allergy to pumpkin seed defined by a suggestive clinical history of IgE-mediated pumpkin seed allergy and positive SPT to pumpkin seed (≥ 6 mm) and/or IgE to pumpkin seed > 0.35 KU/L and/or BAT confirming pumpkin seed allergy diagnosis OR Allergy to sunflower seed defined by a suggestive clinical history of IgE-mediated sunflower seed allergy and positive SPT to sunflower seed (≥ 6 mm) and/or IgE to sunflower seed > 0.35 KU/L and/or BAT confirming sunflower seed allergy diagnosis
Exclusion criteria
Blood sample and skin prick tests in addition to the blood tests and skin prick tests originally scheduled for the patient's care
Time frame: enrollment visit
This sensitization is assessed using three independent methods, each with predefined positivity thresholds of which i) Skin prick tests using native hemp seeds with positive results defined as: Wheal diameter ≥ 6 mm and Erythema larger than the wheal A patient will be considered to have a hemp seeds allergy if the prick test is positive (regardless of the results of the other two tests) or if the other two tests are positive while the hemp seeds prick test is < 6 mm.
Time frame: enrollment visit
This sensitization is assessed using three independent methods, each with predefined positivity thresholds of which ii) IgE reactivity to a total protein extract of hemp seed (≥ 10 ng/mL) A patient will be considered to have a hemp seeds allergy if the prick test is positive (regardless of the results of the other two tests) or if the other two tests are positive while the hemp seeds prick test is < 6 mm.
Time frame: enrollment visit
This sensitization is assessed using three independent methods, each with predefined positivity thresholds of which iii) Basophil activation test (BAT) with a positivity threshold set at > 10% degranulation.
A patient will be considered to have a hemp seeds allergy if the prick test is positive (regardless of the results of the other two tests) or if the other two tests are positive while the hemp seeds prick test is < 6 mm.
Time frame: enrollment visit
To estimate the proportion of patients sensitized to hemp leaves among:
subjects allergic or suspected of being allergic to cannabis (including hemp), subjects allergic to tree nuts (e.g., hazelnuts or walnuts), subjects allergic to seeds (e.g., sunflower, sesame, etc.)
Time frame: enrollment visit
IgE reactivity profiles based on four tests :
Commercial extracts used in routine clinical practice:
Time frame: enrollment visit
Contact information is provided by the study sponsor or research team.
University Hospital, Angers
Other Gov
Acronym: ARCANA-Clinic
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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