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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00826189
Enrollment
253
Registered
2009-01-22
Start date
2009-05-31
Completion date
2013-06-30
Last updated
2014-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Asthma

Keywords

Probiotics, Asthma, Allergic Rhinitis

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.

Interventions

None listed

Sponsors

National University of Singapore
CollaboratorOTHER
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Asthma7 years of age

Secondary

MeasureTime frame
Allergic Rhinitis7 years of age

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026