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

National University Health System (NUHS)

Status: Completed

Conditions: Asthma; Allergic Rhinitis

Study type: Observational

Funder types: Other

Identifiers

NCT00826189

SQNU01 (Phase III)

Details and patient eligibility

About

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.

Full 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".

Enrollment: 253 patients

Sex: All

Ages: 5 to 7 years old

Volunteers: Accepts Healthy Volunteers

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