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

Asthma Clinical Trial

Official title:

A 2 Year Prospective Study of Stool Microbiota in Two Diverse Cohorts of Asian (Singaporean and Indonesian) Newborns and Its Influence on Allergy Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713089
• Other study ID #: SQNB01
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: January 7, 2014
• Start date: March 2006
• Est. completion date: November 2009

Study information

• Verified date: January 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Eczema

Locations

Country	Name	City	State
Indonesia	Gadjah Mada University Hospital	Yogyakarta
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Gadjah Mada University

Countries where clinical trial is conducted

Indonesia,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of allergies of eczema, asthma and allergic rhinitis in 2 diverse cohorts (Singaporean and Indonesian)		2 years	No
Secondary	Gastrointestinal flora in Singapore and Indonesia cohorts		1 year	No