NCT00826189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

4.1 years

First QC Date

January 21, 2009

Last Update Submit

January 8, 2014

Conditions

AsthmaAllergic Rhinitis

Keywords

ProbioticsAsthmaAllergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Asthma

    7 years of age

Secondary Outcomes (1)

  • Allergic Rhinitis

    7 years of age

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The subjects who have completed NCT00318695 and NCT00365469 studies will be invited to participate in this study.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital, Singapore

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

AsthmaRhinitis, Allergic

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Lynette Shek, A/Prof

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

  • Marion Aw, A/Prof

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Prof Lynette Shek

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 22, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

SG(1)