Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases- Follow-up to 7 Years
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|ClinicalTrials.gov Identifier: NCT00826189|
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : January 9, 2014
The investigators had conducted an initial double-blind, placebo-controlled clinical trial (NCT00318695) to study the effects of probiotic supplementation from birth to 6 months of age in the incidence of atopic diseases at 2 years old. This is then further investigated up to 5 years of age in a follow-up study NCT00365469 to assess the longer term beneficial effects.
This current study intends to follow-up for another 2 years until 7 years of age as this is critical in the evaluation of respiratory allergies in the form of clinical asthma and allergic rhinitis.
|Condition or disease|
|Asthma Allergic Rhinitis|
This study intends to continue the initial double-blind, placebo-controlled randomized clinical trial (NCT00318695) which involved 253 subjects with a first degree family history of allergic disease. The infants received at least 60ml of commercially available cow's milk based infant formula with or without probiotic supplementation (Bifidobacterium longum [BL999] 1×10*7 colony-forming unit (cfu)/g and Lactobacillus rhamnosus [LPR]2×10*7 cfu/g) daily from the first day of life for the first 6 months. A follow-up study (NCT00365469) up to 5 years of age is currently in process.
This current study plans to continue the follow-up for a further 2 years till the cohort reaches 7 years of age. This study will only involve telephone calls which will be conducted every 3 months to ascertain for symptoms and incidence of respiratory allergic disease.This is critical in the evaluation of asthma and allergic rhinitis which tend to develop later in life and this step-wise, temporal development of respiratory allergies has been described as "Atopic March".
|Study Type :||Observational|
|Actual Enrollment :||253 participants|
|Official Title:||A Follow-up Study to 7 Years of a Randomized, Double-blinded, Placebo-controlled Study on the Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
- Asthma [ Time Frame: 7 years of age ]
- Allergic Rhinitis [ Time Frame: 7 years of age ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826189
|National University Hospital, Singapore|
|Singapore, Singapore, 119074|
|Principal Investigator:||Lynette Shek, A/Prof||National University Hospital, Singapore|
|Principal Investigator:||Marion Aw, A/Prof||National University Hospital, Singapore|