Prophylaxis of atopic and allergic manifestations and activation or modulation of the immune system by Pro-Symbioflor® treatment in newborns / small children from atopically pre-disposed parents.

Completed

Conditions: Atopic dermatitis
Skin and Connective Tissue Diseases

Registration Number: ISRCTN60475069

Lead Sponsor: SymbioPharm GmbH (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 632

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of atopic dermatitis during the treatment phase between the 4th and 31st life week under the prophylaxis with verum or placebo.

Secondary Outcome Measures

Name	Time	Method
1. Incidence of atopic dermatitis after treatment and until end of 3 years<br>2. Time until the first manifestation of an AD<br>3. Severity of AD at manifestation of an eczema: SCORing Atopic Dermatitis (SCORAD) Score<br>4. Frequency and time until the appearance as well as severity of allergic/atopic manifestations in the gastrointestinal tract<br>5. Frequency and until the appearance as well as severity of an allergic/atopic manifestation in the airways<br>6. Frequency of a sensitization against food allergens<br>7. Induction / enhancement of a Th1-immune response<br>8. Toll-like-receptors<br>9. Safety pharmacological Investigations before and at the end of the treatment as well as the observation period<br>10. Adverse events