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
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.
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. |
Observational Model: Ecologic or Community, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Indonesia | Gadjah Mada University Hospital | Yogyakarta | |
Singapore | National University Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore | Gadjah Mada University |
Indonesia, Singapore,
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 |
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