A Phase 2 interventional study of Probiotics and Placebo in Eczema, Asthma and Allergic Rhinitis, sponsored by National University Hospital, Singapore. Completed at 1 site in Singapore. Per ClinicalTrials.gov, last updated 2009-01-22.
Sponsored by National University Hospital, Singapore · Phase 2, Interventional, and Prevention
This will be a double-blind, randomized placebo-controlled study. 253 children were recruited and randomly assigned into one of 2 groups to receive either normal infant formula or formula with Bifidobacterium longum and Lactobacillus rhamnosus GG. The primary aim is to assess the effect of early administration (from birth) of probiotics on the incidence of allergic sensitization, eczema, asthma and rhinitis.
One of the most important early influences on the immune system is the intestinal microflora. The gastrointestinal tract, being the largest body area interacting with the environment, is one of the earliest to be colonized and is quantitatively the most important source of microbial stimulation for the immature immune system. Probiotics are helpful bacteria from healthy intestinal tract, and have shown potential in reducing allergy. This is extremely important as allergic diseases are on the rise worldwide. Probiotics are safe, easy to administer and can be used early for intervention as allergic sensitization, once established, is difficult to reverse.
This double-blind, randomized placebo-controlled study has recruited 253 children from birth. These babies, with a family history of atopic disease, will be randomly assigned into one of 2 groups to receive either normal infant formula or formula with Bifidobacterium longum and Lactobacillus rhamnosus GG. The formula will be consumed postnatally for 6 months, after which the child will continue with normal follow-on milk. Children will be examined at the neonatal period and at 1, 3, 6, 12 and 24 months. Blood samples will be collected at birth (cord blood) and at 1 year of age. Blood will be analyzed for cytokines, total IgE and specific IgE. Skin prick test for common allergens will also be performed at 1 year of age. Stools will be collected at 5 days, 1, 3, 12 months and analyzed for the pattern of stool colonization.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 253 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bifidobacterium longum \[BL999\] and Lactobacillus rhamnosus \[LPR\]
Dietary Supplement: Probiotics
Commercially available cow's milk based infant formula without probiotic supplementation
Other: Placebo
Bifidobacterium longum \[BL999\] and Lactobacillus rhamnosus \[LPR\]
Commercially available cow's milk based infant formula without probiotic supplementation
Atopic eczema by 2 years of age
Asthma by 2 years of age
Allergic Rhinitis by 2 years of age
Allergen sensitization by 2 years of age
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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National University Hospital, Singapore