NCT00318695

Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses

Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses- A Randomized Double-Blind Placebo Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Eczema
• Asthma
• Allergic Rhinitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics	Bifidobacterium longum \[BL999\] and Lactobacillus rhamnosus \[LPR\]
OTHER	Placebo	Commercially available cow's milk based infant formula without probiotic supplementation

Timeline

• Start date: 2004-05-01
• Primary completion: 2008-07-01
• Completion: 2009-01-01
• First posted: 2006-04-27
• Last updated: 2009-01-22

Locations

1 site across 1 country: Singapore