Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases- Follow-up to 7 Years

Completed

• Conditions: Asthma; Allergic Rhinitis

• Registration Number: NCT00826189
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Study Start: 2009-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

• Subject has completed the both NCT00318695 and NCT00365469 studies.
• Parent(s) / Guardian consent to the subject's participation in the study.
• Subject and the parent(s)/ guardian are willing to comply with the study procedures

Exclusion Criteria

• The parent is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained.
• The parent is unable/ unwilling to comply with study procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma	7 years of age

Secondary Outcome Measures

Name	Time	Method
Allergic Rhinitis	7 years of age

Trial Locations

Locations (1)

National University Hospital, Singapore; 🇸🇬 Singapore, Singapore