DRKS00003958已完成未知
A Multicenter Randomized, Controlled Clinical Study on the Effect of a Probiotic (Lactobacillus casei Shirota) on the Immune Response to Influenza Vaccination
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 638
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 one（—）
- 性别
- All
入选标准
- •? Free-living adults aged = 50 years willing to have influenza vaccination season 2011/2012
- •? willingness to abstain from food and supplements containing probiotics, prebiotics and other fermented products
- •? written informed consent
排除标准
- •? Subjects enrolled in another clinical study in the last 4 weeks
- •? Subjects already vaccinated against influenza during 2011-2012 with either the influenza vaccine used in the present study or another influenza vaccine.
- •? Subjects previously vaccinated against influenza during 2010-2011
- •? Subjects previously vaccinated against pandemic influenza in 2009 or 2010 with an influenza pandemic vaccine (A/H1N1)
- •? known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
- •? active autoimmune diseases
- •? allergy or hypersensitivity to any component of the vaccine (e. g. chicken egg protein, certain antibiotics)
- •? allergy or hypersensitivity to any component of the test product (e.g. milk protein)
- •? suffering from influenza or influenza-like illness in the current winter season (since Nov. 2011)
- •? symptoms of common infectious diseases (CID) of the airways or other organ systems e.g. gastrointestinal tract in the last 4 weeks before inclusion.
- •? severe chronic disease (cancer, IBD, malabsorption, malnutrition, chronic inflammatory diseases, renal, hepatic or cardiac diseases, respiratory insufficiency)
- •? chronic abdominal pain
- •? systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, intestinal or respiratory antiseptics, antirheumatics, antiphlogistics (except aspirin or equivalent products preventing from aggregation of platelets or blood clotting) and steroids prescribed in chronic inflammatory diseases
- •? other treatments likely to interfere with study outcome (e.g. laxatives, body weight management and/or medication)
- •? lactose intolerance
- •? diabetes mellitus on drug therapy
- •? severe neurological, cognitive or psychiatric diseases
- •? surgery or intervention requiring general anaesthesia within 2 months before the study
- •? pregnancy or lactation
- •? eating disorders or special diets (e.g. vegan)
- •? alcohol and products abuse
- •? legal incapacity
研究者
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