Allergic Rhinitis, Asthma, Eczema
Conditions
Keywords
Probiotics, Eczema, Asthma, Allergic Rhinitis, Prevention, Immunological responses
Brief 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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Bifidobacterium longum \[BL999\] and Lactobacillus rhamnosus \[LPR\]
OTHERPlacebo
Commercially available cow's milk based infant formula without probiotic supplementation
Sponsors
National University of Singapore
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma | 5 years of age |
Secondary
| Measure | 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 |
Countries
Singapore
Outcome results
None listed