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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826189
• Other study ID #: SQNU01 (Phase III)
• Status: Completed
• Phase: N/A
• First received: January 21, 2009
• Last updated: January 8, 2014
• Start date: May 2009
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 7 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma

Locations

Country	Name	City	State
Singapore	National University Hospital, Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma		7 years of age	No
Secondary	Allergic Rhinitis		7 years of age	No