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A trial of the effect of probiotics on the development of atopy and eczema in children

A trial of the effect of probiotics on the development of atopy and eczema in children

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000518460
Enrollment
474
Registered
2007-10-09
Start date
2004-01-21
Completion date
2005-05-26
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Probiotics (found in fermented foods) when given to infants may exert a protective effect on the development of allergy by influencing the developing immune system. This study aims to determine whether dietary supplementation in infants with 2 different probiotics results in differences in atopy and eczema prevalence at age 2 years.

Interventions

Study interventions were the probiotics, Lactobacillus rhamnosus (10**9 colony forming units) and Bifidobacteria lactis (10**9 colony forming units) administered orally. In mothers this was taken daily from 35 weeks gestation till 6 months if breastfeeding. In infants this was administered daily from birth for 2 years.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

a) Pregnant women at least 37 weeks gestation b) Pregnant women where they or their partner has a history of asthma, hay fever of eczema treated by a doctor.

Exclusion criteria

a) Planning to move from study centres during study period b) Birth weight lower than the 3rd percentile for gender and gestation c) Infant admission to neonatal unit for at least 48 hours d) Serious congenital abnormalities e) Long-term probiotic use in mother f) Mother intends to give probiotics to child if they develop eczema g) Mother has taken less than 2 weeks study probiotics during pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 26, 2026