NCT01896154已完成1 期
A Randomized, Controlled Clinical Study on the Effect of Non-digestible Polysaccharides (NPS) on the Immune Response to Influenza Vaccination in Elderly
Clinical Research Center Kiel GmbH0 个研究点目标入组 239 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 主要终点
- Geometric mean titre of antibodies against one of the 3 influenza strains in HI test
研究概览
简要总结
The aim of the study is to estimate the effect size of a 5-week consumption period of different dietary non-digestible polysaccharides (NPS) on antibody response to influenza vaccination and cellular immunity of healthy volunteers (aged ≥ 50) for clarifying whether these NPS may enable enhancement of immune defence and to estimate the sample size for a confirmative trial. Furthermore the effects on faecal microbiota and its metabolites will be investigated.
详细描述
The study is conducted in the frame of the collaborative project 'FibeBiotics' (Nr. 289517) (Fibers as support of the Gut and Immune function of Elderly - From polysaccharide compound to health claim) within the Seventh Framework Programme (FP7) for Research and Technological Development of the European Union (EU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Free-living postmenopausal woman and men aged ≥ 50 years willing to have influenza vaccination season 2012/2013
- •willingness to abstain as far as possible from food and supplements containing probiotics, prebiotic supplements, other fermented products, supplements containing vitamins and minerals as well as willing to sustain on a low dietary fibre diet for 7 weeks.
- •written informed consent
排除标准
- •Subjects enrolled in another clinical study in the last 4 weeks
- •Subjects already vaccinated against influenza during 2012-2013 with either the influenza vaccine used in the present study or another influenza vaccine
- •vaccination against influenza within the previous 10 months
- •suffering from influenza or influenza-like illness within the previous 10 months
- •other vaccinations during and within 2 months before the study
- •symptoms of common infectious diseases (CID) of the airways or other organ systems e.g. gastrointestinal tract in the last 4 weeks before inclusion
- •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)(s. a. 9.2)
- •allergy or hypersensitivity to any component of the test product (e. g. yeast, gluten, shiitake mushrooms)
- •allergy to latex
- •known coeliac disease (gluten enteropathy)
- •bowel movement less than 3 times per week
- •subjects, who meet 2 or more Rome III criteria for constipation or who take laxatives on a regular basis
- •severe chronic disease (cancer, IBD, malabsorption, malnutrition, chronic inflammatory diseases, renal, hepatic or cardiac diseases, COPD, respiratory insufficiency)
- •chronic abdominal pain
- •malformation of fingers
- •systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, 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)
- •treatments with calcium antagonists and nitrates and alpha blockers
- •diabetes mellitus on drug therapy
- •severe neurological, cognitive or psychiatric diseases
- •surgery or intervention requiring general anaesthesia within 2 months before the study
- •vegetarian, vegan
- •eating disorders (e.g. anorexia, bulimia)
- •alcohol and drug abuse
- •pregnancy or lactation
- •legal incapacity
- •blood parameters: Hb < 12 g/dL Liver transaminases (ALT, AST) > 2-fold increased Serum creatinine > 1,2 mg/dL
结局指标
主要结局
Geometric mean titre of antibodies against one of the 3 influenza strains in HI test
时间窗: 3 weeks after vaccination
次要结局
未报告次要终点
研究者
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