Prophylaxis by Pro-Symbioflor® of atopic and allergic manifestations and activation or modulation of the immune system in newborns / small children from atopically pre-disposed parents. Prospective, randomized, placebo-controlled, double-blind parallel group trial in 632 healthy newborns aged 4 weeks with increased risk for atopic dermatitis with repeated application of Pro-Symbioflor® t.i.d or placebo between 2 and 7 months of age and an observation period until the age of 3 years.

SymbioPharm GmbH (Germany)0 个研究点目标入组 632 人开始时间: 2010年9月15日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Healthy male and female newborns aged 4 weeks
•2. Regularly developed newborns - body weight: = 2500 g; gestational age > 37+0 weeks
•3. No relevant illnesses since the birth (except transient Hyperbilirubinemia)
•4. Positive atopic anamnesis with at least one parent (atopic dermatitis, bronchial asthma, allergic rhino-conjunctivitis)
•5. Written informed consent by the parents as the legal representatives

•1. Diseases that require immunosuppressive therapy (systemic administration of steroids or cyclosporine A)
•2. Transfer to an intensive care unit after birth
•3. Known immune disturbances or defects (Lymphopenia, Thrombopenia)
•4. Concomitant medication or treatment (except for prophylaxis)
•5. Inadequate ability or willingness of the parents to communicate or to cooperate
•6. Family anamnesis of a congenital deficiency in immune defence

发起方

SymbioPharm GmbH (Germany)