Asthma Clinical Trial
Official title:
A Follow-up Study to 7 Years of a Randomized, Double-blinded, Placebo-controlled Study on the Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases
The investigators had conducted an initial double-blind, placebo-controlled clinical trial
(NCT00318695) to study the effects of probiotic supplementation from birth to 6 months of
age in the incidence of atopic diseases at 2 years old. This is then further investigated up
to 5 years of age in a follow-up study NCT00365469 to assess the longer term beneficial
effects.
This current study intends to follow-up for another 2 years until 7 years of age as this is
critical in the evaluation of respiratory allergies in the form of clinical asthma and
allergic rhinitis.
This study intends to continue the initial double-blind, placebo-controlled randomized
clinical trial (NCT00318695) which involved 253 subjects with a first degree family history
of allergic disease. The infants received at least 60ml of commercially available cow's milk
based infant formula with or without probiotic supplementation (Bifidobacterium longum
[BL999] 1×10*7 colony-forming unit (cfu)/g and Lactobacillus rhamnosus [LPR]2×10*7 cfu/g)
daily from the first day of life for the first 6 months. A follow-up study (NCT00365469) up
to 5 years of age is currently in process.
This current study plans to continue the follow-up for a further 2 years till the cohort
reaches 7 years of age. This study will only involve telephone calls which will be conducted
every 3 months to ascertain for symptoms and incidence of respiratory allergic disease.This
is critical in the evaluation of asthma and allergic rhinitis which tend to develop later in
life and this step-wise, temporal development of respiratory allergies has been described as
"Atopic March".
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