NCT00365469

Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora - Follow-up to 5 Years

A Follow-up Study to 5 Years of a Randomized, Double-blinded, Placebo-controlled Study on the Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora

• 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

The investigators had conducted a double-blind, randomized placebo-controlled clinical trial studying the effects of 6 months probiotics supplementation from birth on allergic disease and sensitization up to 2 years of age. This follow-up study will extend a further 3 years to 5 years of age for assessing the longer term beneficial effects of this form of probiotics intervention on the incidence of allergic disease and sensitization at 5 years of age.

Detailed description

Probiotics are helpful bacteria of healthy gut and have shown potential in reducing allergy. A double-blind, randomized placebo-controlled clinical trial studying the effects of 6 months probiotics supplementation from birth on allergic disease and sensitization up to 2 years of age had been conducted. This study aims to assess the longer term beneficial effects of this form of intervention on the incidence of allergic disease and sensitization at 5 years of age by extending the follow-up period. All children (from original cohort of 253) who completed the initial 2-year visit has been invited to participate. They will be evaluated with monthly phone calls and yearly clinic visits. Allergic sensitization will be assessed with skin prick tests to a panel of allergens. This project will provide insights into the role of early supplementation of probiotics on the development of the immune system and its effect on allergy. The additional follow-up period is critical for the evaluation of respiratory allergies in the form of clinical asthma, allergic rhinitis and sensitization to inhalant allergens, which tend to develop after 2 years of age.

Conditions

• Eczema
• Asthma
• Allergic Rhinitis

Interventions

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

Timeline

• Start date: 2006-05-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2006-08-17
• Last updated: 2014-01-09

Locations

1 site across 1 country: Singapore