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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Eczema, Asthma, Allergic Rhinitis

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Other: Placebo


Participation Criteria
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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. Exclusion Criteria: The parent is unable /unwilling to comply with procedures.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Commercially available cow's milk based infant formula with Bifidobacterium longum [BL999} and Lactobacillus rhamnosus [LPR] | Dietary Supplement: Probiotic<br>* Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]<br>|
| Placebo Comparator: Placebo<br>Commercially available cow's milk based infant formula without probiotic supplementation | Other: Placebo<br>* Commercially available cow's milk based infant formula without probiotic supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma |  | 5 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atopic eczema |  | 5 years of age | 
| Allergic Rhinitis |  | 5 years of age | 
| Allergen sensitization |  | 5 years of age | 
| Food Allergy |  | 5 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema, Asthma, Probiotics, Allergic Rhinitis, Prevention, Immunological responses