Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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

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Eczema Asthma Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Probiotic

Commercially available cow's milk based infant formula with Bifidobacterium longum \[BL999} and Lactobacillus rhamnosus \[LPR\]

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium longum \[BL999\] and Lactobacillus rhamnosus \[LPR\]

Placebo

Commercially available cow's milk based infant formula without probiotic supplementation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Commercially available cow's milk based infant formula without probiotic supplementation

Interventions

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Probiotic

Bifidobacterium longum \[BL999\] and Lactobacillus rhamnosus \[LPR\]

Intervention Type DIETARY_SUPPLEMENT

Placebo

Commercially available cow's milk based infant formula without probiotic supplementation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Parents agree to the subject's participation in the study and informed consent has been obtained.
* The subject has been a participant in the Phase I double-blind, randomized placebo-controlled study and had taken either normal infant formula or formula supplemented with probiotics postnatally for 6 months.
* The parents are willing to comply with study procedures and are able to keep to scheduled clinic visits.