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

Phase 3

Completed

• Conditions: Eczema,Atopy; Eczema,; Atopy; Skin - Dermatological conditions; Public Health - Epidemiology

• Registration Number: ACTRN12607000518460
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 510

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atopy was measured using skin prick tests.[At 24 mths, 4 yrs, 6 yrs and 11 yrs of age];Eczema is defined according to the UK Working Party's Diagnostic Criteria for Atopic Dermatitis, modified for use in children under 2 years.[At age 3 mths, 6 mths, 12 mths, 18 mths, 24 mths, 4 yrs, 6 yrs and 11 yrs of age];Specific and total IgE. After administration of topical anaesthesia, 3.5 ml of blood was sampled. Serum specific IgE (ssIgE) was analysed using the Phadia ImmunoCAP ssIgE fluorescence enzyme immunoassay (Phadia AB, Uppsala, Sweden). Total IgE was analysed using Roche Cobas e601 total IgE electrochemiluminescence immunoassy (Roche DiagnosticsGmbH, D-68298 Mannheim, Germany)[6 years]