Effect of probiotics in the primary prevention of atopic eczema

Effect of probiotics (Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus) in the primary prevention of atopic dermatitis: a double-blind, randomised, placebo-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26134979

Enrollment

110

Registered

2009-05-27

Start date

2005-01-01

Completion date

Unknown

Last updated

2019-07-29

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

Conditions

Atopic eczema Skin and Connective Tissue Diseases Atopic dermatitis

Interventions

The selected participants were assigned to treatment groups by computerised block-randomisation and received either probiotics or placebo. Mothers in the probiotics group took a mixture of Bifidobacte

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Pregnant adult women with a family history of atopic diseases. A positive family history was defined as the presence of at least one first-degree family member having AD, asthma, or allergic rhinitis. The AD of members of the participants' families was confirmed by a physician at enrolment. Those who had been diagnosed as having asthma or allergic rhinitis were selected only when they showed house dust mite-specific immunoglobulin E (IgE) over 1.0 kU/l by cap-system fluorescent enzyme immunoassay (CAP-FEIA) (Pharmacia, Uppsala, Sweden).

Exclusion criteria

Exclusion criteria: 1. Babies with a congenital disorder 2. Premature babies

Design outcomes

Primary

Measure	Time frame
1. Rate of caesarean delivery, collected at 3 months of infant's age 2. Total duration of the breastfeeding, collected at 3, 6, and 12 months of infant's age 3. Infections, collected at 3, 6, and 12 months of infant's age 4. Antibiotic use, collected at 3, 6, and 12 months of infant's age 5. Hospitalisation during infancy, collected at 3, 6, and 12 months of infant's age 6. Prevalence of respiratory infection and acute gastroenteritis, collected at 3, 6, and 12 months of infant's age 7. Frequency of fever above 38.5°C, collected at 3, 6, and 12 months of infant's age 8. Serious adverse events related to the administration of probiotics, collected at 3, 6, and 12 months of infant's age	—

Measure

Time frame

1. Rate of caesarean delivery, collected at 3 months of infant's age 2. Total duration of the breastfeeding, collected at 3, 6, and 12 months of infant's age 3. Infections, collected at 3, 6, and 12 months of infant's age 4. Antibiotic use, collected at 3, 6, and 12 months of infant's age 5. Hospitalisation during infancy, collected at 3, 6, and 12 months of infant's age 6. Prevalence of respiratory infection and acute gastroenteritis, collected at 3, 6, and 12 months of infant's age 7. Frequency of fever above 38.5°C, collected at 3, 6, and 12 months of infant's age 8. Serious adverse events related to the administration of probiotics, collected at 3, 6, and 12 months of infant's age

—

Secondary

Measure	Time frame
1. Effects of probiotics on development of atopic dermatitis, collected at 3, 6, and 12 months of infant's age 2. Severity of AD, assessed by the Six Area Six Sign Atopic Dermatitis (SASSAD) scoring system, collected at 3, 6, and 12 months of infant's age 3. IgE sensitisation, measured at 1 year of infants' age	—

Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026