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Probiotics in the prevention of atopy in infants and children

Probiotics in the prevention of atopy in infants and children (PROBAT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26287422
Enrollment
600
Registered
2005-06-15
Start date
2005-05-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Atopy in infants and children Signs and Symptoms Atopy

Interventions

Active intervention: probiotic supplement consisting of a combination of 4 strains of live bacteria (Lactobacillus salivarius LS33 6.25 x 10^9 cfu [Colony Forming Units], Lactobacillus paracasei CUL08

Sponsors

University of Wales, Swansea (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 600 women and their newborn infants recruited from the antenatal department of a maternity unit of a district general hospital, with informed written consent. Infants have a first degree relative with an atopic disorder.

Exclusion criteria

Exclusion criteria: 1. Mother aged less than 16 years 2. Multiple pregnancy 3. Gestation at delivery less than 36 weeks 4. Parents unable or unwilling to give informed consent 5. Any adverse medical condition affecting the pregnancy or its likely outcome (e.g. known abnormality in foetus) 6. Member of sibship or household already recruited to the study

Design outcomes

Primary

MeasureTime frame
1. The presence of eczema during infancy (assessed by the SCORAD system) 2. The presence of asthma in children in the first five years 3. Changes in key immunological parameters associated with atopy

Secondary

MeasureTime frame
1. Compliance with/adherence to trial intervention 2. Adverse events

Countries

United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026