NCT02552537已完成4 期
Integrated Approaches to Food Allergen and Allergy Risk Management: iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- amount of walnuts that induces an allergic reaction assessed in milligram
研究概览
简要总结
In patients with a walnut allergy double blind placebo controlled food challenge with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on threshold level and on clinical manifestation.
详细描述
- detailed case history, blood sampling and prick testing with different foods will performed.
- double blind food provocation with with three meals containing either placebo or walnut in walnut allergic patients will be performed.
- the provocation will be combined with the intake of drug (omeprazole) or placebo (mannitol) blinded in capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent, history of walnut allergy,minimum age 18 years
排除标准
- •• Known hypersensitivity or allergy to Omeprazole, other proton pump inhibitors, mannitol, ingredients of placebo meal
- •Drugs not allowed during the study due to proved interaction with Omeprazole: Digoxin, Clopidogrel, Methotrexate, Antiretroviral drugs, Diazepam, Cilostazol, Phenytoin, Warfarin (R-Warfarin) and other Vitamin K antagonists, Phenytoin, Tacrolimus, Clarithromycin, voriconazole, Rifampicin and Hypericum
- •Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge)
- •corticosteroids systemically (2 weeks)
- •antihistamines (3 days) except hydroxyzine (10 days)
- •ketotifen (2 weeks)
- •betablocker (1 day)
- •angiotensin converting enzyme (ACE) inhibitors (2 days)
- •omalizumab (2 months)
- •Women who are pregnant or breast feeding
- •Intention to become pregnant during the course of the study
- •Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices
- •Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- •Uncontrolled asthma, forced expiratory volume <70% predicted value
- •Acute allergic disease
- •Chronic urticaria
- •Mastocytosis
- •Other clinically significant concomitant disease states (major organic or infectious diseases, e.g., renal failure, hepatic dysfunction, cardiovascular disease, acute febrile infection),
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
研究组 & 干预措施
Omeprazole
Active Comparator
patients will take Omeprazole 40mg, in capsules, once a day, during five days before walnut challenge
干预措施: Omeprazole (Drug)
Placebo
Sham Comparator
patients will take Mannitol, in capsules, once a day, during five days before walnut challenge
干预措施: Placebo (Drug)
结局指标
主要结局
amount of walnuts that induces an allergic reaction assessed in milligram
时间窗: up to 18 months
The amount of walnut which induces an allergic reaction in walnut allergic patients will be assessed in milligram by titrated challenges under concommitant intake of therapeutic doses of omeprazole versus placebo
次要结局
未报告次要终点
研究者
研究点 (2)
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