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临床试验/NCT07652853
NCT07652853尚未招募不适用

Allergenic Risk Assessment of Hemp Seed

University Hospital, Angers0 个研究点目标入组 35 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
35

研究概览

简要总结

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.

详细描述

All study-specific examinations are performed during the enrollment visit, which takes place during a routine medical visit

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 2 years or older
  • Belonging to one or more of the target populations:
  • 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
  • Patients referred to the Allergy Unit at Angers University Hospital (CHU d'Angers) for skin prick testing, either in outpatient consultation or during hospitalization
  • Patients affiliated with or beneficiaries of a social security system
  • Patient or legal representative having signed an informed consent form

排除标准

  • Pregnant women or women in labor
  • Individuals deprived of liberty by an administrative or judicial decision
  • Individuals undergoing involuntary psychiatric care
  • Adults under a legal protection measure
  • Individuals unable to express their consent
  • Poor understanding of the French language
  • Patients whose skin reactivity prevents the interpretation of the tests

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

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