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.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60475069

Enrollment

632

Registered

2010-09-15

Start date

2002-05-28

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis

Interventions

1. Intervention group: Pro-Symbioflor® (verum): Bacterial lysate manufactured from 1,5 ? 4,5 x 10E+07 Enterococcus faecalis (DSM 16440) and 1,5 ? 4,5 x 10E+07 Escherichia coli (DSM 17252). 3x5 drops p

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026