NCT00713089

Brief Summary

This study aims to document prospectively the incidence of allergies of eczema, asthma and allergic rhinitis in 2 diverse cohorts (Singaporean and Indonesian) with contrasting lifestyles and socioeconomic development. The profile of microbial colonization in terms of species variety, as well as their genetic diversity will be studied in Singapore and Indonesia cohorts and to correlate these with clinical allergy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2006

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

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

Study Start

First participant enrolled

March 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 8, 2014

Status Verified

January 1, 2014

Enrollment Period

3.7 years

First QC Date

July 7, 2008

Last Update Submit

January 7, 2014

Conditions

EczemaAsthmaAllergic Rhinitis

Keywords

EczemaAsthmaAllergic rhinitisSingaporeIndonesiaGastrointestinal Flora

Outcome Measures

Primary Outcomes (1)

  • Incidence of allergies of eczema, asthma and allergic rhinitis in 2 diverse cohorts (Singaporean and Indonesian)

    2 years

Secondary Outcomes (1)

  • Gastrointestinal flora in Singapore and Indonesia cohorts

    1 year

Study Arms (2)

1

75 subjects randomised into the placebo arm of an ongoing randomised double-blind placebo controlled clinical trial at National University Hospital, Singapore

2

The expecting mothers visiting at the well mother clinics at Gadjah Mada University Hospital were invited to participate in the study

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

75 subjects randomised into the placebo arm of an ongoing randomised double-blind placebo controlled clinical trial at National University Hospital, Singapore. For Indonesia Cohort, the expecting mothers visiting at the well mother clinics at Gadjah Mada University Hospital were invited to participate in the study.

You may qualify if:

  • Pre-delivery evaluation
  • Either parent or sibling (ie first degree relative) has a history of atopy. This will be evidenced by a doctor-diagnosis of asthma, allergic rhinitis or eczema AND a positive skin prick test/specific IgE test to any of a panel of common allergens.
  • Parents agree to the child's participation in the study and sign the Informed Consent.
  • The subject and the parents are willing to comply with procedures and both child and parents are able to keep to scheduled clinic visits.
  • Both parents are at contactable range (with valid mobile or land line numbers) for study team to arrange and schedule clinic visits and complete telephone interviews.
  • Post-delivery evaluation
  • The subject is born full term (at least 37 weeks gestation).
  • The subject does not have major congenital malformations/major illness as judged by the doctor.
  • The subject is in otherwise good, stable health on the basis of medical history, physical examination.
  • Family appears to be able to successfully complete this study.

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 procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gadjah Mada University Hospital

Yogyakarta, 55281, Indonesia

Location

National University Hospital

Singapore, 119074, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stools samples will be collected between 72 to 120 hours (or 3 to 5 days) and at 1, 3 and 12 months of age.

MeSH Terms

Conditions

EczemaAsthmaRhinitis, Allergic

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Bee Wah Lee, MD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 11, 2008

Study Start

March 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 8, 2014

Record last verified: 2014-01

Locations

SG(1)ID(1)