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.

Study Overview

• Status: Completed
• Conditions: Asthma; Allergic Rhinitis; Eczema

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• Indonesia
  • Yogyakarta, Indonesia, 55281
    • Gadjah Mada University Hospital
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of allergies of eczema, asthma and allergic rhinitis in 2 diverse cohorts (Singaporean and Indonesian)	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Gastrointestinal flora in Singapore and Indonesia cohorts	1 year

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Collaborators: Gadjah Mada University
• Investigators: Principal Investigator: Bee Wah Lee, MD, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 7, 2008
• First Posted (Estimate): July 11, 2008

Study Record Updates

• Last Update Posted (Estimate): January 8, 2014
• Last Update Submitted That Met QC Criteria: January 7, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Asthma; Indonesia; Eczema; Allergic rhinitis; Singapore; Gastrointestinal Flora
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Dermatitis; Skin Diseases, Eczematous; Rhinitis; Rhinitis, Allergic; Eczema
• Other Study ID Numbers: SQNB01