Clinical trial NCT00826189: Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases- Follow-up to 7 Years
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Allergic Rhinitis
Keywords: Probiotics
Asthma
Allergic Rhinitis
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2009-01-22
Enrollment: 253
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects who have completed NCT00318695 and NCT00365469 studies will be invited to participate in this study.

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".

Eligibility criteria: 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

Primary outcomes:
measure: Asthma
timeFrame: 7 years of age
Secondary outcomes:
measure: Allergic Rhinitis
timeFrame: 7 years of age
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
Study officials:
affiliation: National University Hospital, Singapore
name: Lynette Shek, A/Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Hospital, Singapore
name: Marion Aw, A/Prof
role: PRINCIPAL_INVESTIGATOR
References: