Study of Stool Microbiota in Two Diverse Cohorts of Asian and Its Influence on Allergy Development

This study has been completed.
Sponsor:
Collaborator:
Gadjah Mada University
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00713089
First received: July 7, 2008
Last updated: January 7, 2014
Last verified: January 2014

July 7, 2008
January 7, 2014
March 2006
November 2009   (final data collection date for primary outcome measure)
Incidence of allergies of eczema, asthma and allergic rhinitis in 2 diverse cohorts (Singaporean and Indonesian) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00713089 on ClinicalTrials.gov Archive Site
Gastrointestinal flora in Singapore and Indonesia cohorts [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Stool Microbiota in Two Diverse Cohorts of Asian and Its Influence on Allergy Development
A 2 Year Prospective Study of Stool Microbiota in Two Diverse Cohorts of Asian (Singaporean and Indonesian) Newborns and Its Influence on Allergy Development

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.

The main objective of the current study is to establish the relationship of gut microbiota and development of allergy in 2 populations with different socioeconomic status and prevalence of allergy (high in Singapore and low in Indonesia). A cohort of children will be followed prospectively from birth up to 2 years. Stool from different time points, environmental exposure data and clinical manifestations of allergy will be analyzed and recorded. Singapore and Indonesia will provide the South East Asian context in resolving early life influences associated with divergent allergy prevalence. By studying subjects below age two, this will provide valuable knowledge regarding the epidemiology of allergy and atopy in the first years of life, which is poorly documented in this age group. More importantly, the prospective nature and varied parameters included in this study (colony counts, species variety and genetic diversity of microbiota) will add to the global data and scientific evidence for the role of these factors in allergy development.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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.

  • Eczema
  • Asthma
  • Allergic Rhinitis
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

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 procedures.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Indonesia,   Singapore
 
NCT00713089
SQNB01
No
National University Hospital, Singapore
National University Hospital, Singapore
Gadjah Mada University
Principal Investigator: Bee Wah Lee, MD National University Hospital, Singapore
National University Hospital, Singapore
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP