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

NCT ID: NCT00713089

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-11-30

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.

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.

Conditions

Eczema; Asthma; Allergic Rhinitis

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

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

No interventions assigned to this group

2

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

No interventions assigned to this group

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gadjah Mada University

OTHER

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bee Wah Lee, MD

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

Gadjah Mada University Hospital

Yogyakarta, , Indonesia

National University Hospital

Singapore, , Singapore

Countries

Indonesia; Singapore

Other Identifiers

SQNB01

Identifier Type: -

Identifier Source: org_study_id