DRKS00017688尚未招募未知
A placebo-controlled, randomized, double-blind study to assess the efficacy of a specific probiotic formulation in the reduction of recurrent respiratory tract infections (RTIs) and antibiotic prescriptions - MIC01-RTI
Microbiotica GmbH0 个研究点目标入组 354 人开始时间: 2019年9月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 354
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
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age 18 and older
- •Patients starting antibiotic treatment (oral or i.v.) for any cause for not more than 14 days
- •Patients with a history of 2-4 episodes of RTI during the last 12 months before inclusion
- •Patients with a history of 1-4 antibiotic therapies (oral or i.v.) for any cause during the last 12 months before inclusion
- •Patients able to understand and follow study procedures
- •Signed Informed Consent Form
排除标准
- •Acute and chronic diarrhea at inclusion
- •People who never had a flu vaccination before, but had one for the period covering the study duration (autumn/winter 2019/2020) or are planning a vaccination for this period.
- •Intake of probiotic supplements and/or medications 4 weeks prior and/or during the study
- •Severe COPD (GOLD grade IV or group D)
- •Severe asthma (eosinophilic or asthma, treated with monoclonal antibodies)
- •Immunodeficiency (e.g. HIV, chemo-, radio- , immune therapy) in the last 12 months or during the study
- •Long term use of immune suppressant or immune stimulating prescription medication (e.g. interferon, growth factor, monoclonal antibodies, etc.)
- •Subjects presenting with an active, non-controlled intestinal disease such as Crohn’s disease or ulcerative colitis
- •A previous documented C. difficile infection <3 months prior to study initiation
- •Severe organ or systemic disease which will influence the conduct of the study based on the physician´s assessment as well as any health condition that will not allow to follow study procedures or compliance
- •Alcohol addiction or abuse
- •Drug addiction or abuse
- •Known hypersensitivity to the any ingredient of the study product
- •Current participation in another clinical trial or participation in another clinical trial within the last 30 days
研究者
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