EUCTR2015-002733-22-IT进行中（未招募）1 期
Combined treatment with pidotimod and bifidobacteria in pre-scholastic age children with recurrent respiratory infections: evaluation of clinical efficacy and parents' quality of life - MB0515/1021/03
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- both sex aged 3-6 years;
- •- integrated in scholastic ambient (nursery school, kindergarten);
- •- affected by recurrent respiratory infections defined as:
- •.. 6 or more episodes in the previous year: 01/10/2014 - 30/09/2015;
- •.. 1 or more episodes/month in the period september-april of the previous year: 01/09/2014 - 20/054/2015;
- •.. 3 or more lower respiratory tract infections in the previous year: 01/10/2014 - 30/09/2015;
- •- whose parents have given the appropriate consent to the study partecipation of their son.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- ongoing respiratory infection or other infections requiring hospitalization;
- •- story of bronchospasm;
- •- cardiopathies or severe systemic disease;
- •- chronic respiratory diseases (like cystic fibrosis and primary ciliary dyskinesia);
- •- immunodeficiencies;
- •- treatment in the last 4 weeks with probiotics, corticosteroids, immunostimulants or immunosuppressants;
- •- allergies or intolerance to pidotimod.
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