Study of Stool Microbiota in Two Diverse Cohorts of Asian and Its Influence on Allergy Development
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
|---|
|
Eczema Asthma Allergic Rhinitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Prospective |
| 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 |
- 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 ]
- Gastrointestinal flora in Singapore and Indonesia cohorts [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Stools samples will be collected between 72 to 120 hours (or 3 to 5 days) and at 1, 3 and 12 months of age.
| Estimated Enrollment: | 143 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
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.
Contacts and Locations| Indonesia | |
| Gadjah Mada University Hospital | |
| Yogyakarta, Indonesia, 55281 | |
| Singapore | |
| National University Hospital | |
| Singapore, Singapore, 119074 | |
| Principal Investigator: | Bee Wah Lee, MD | National University Hospital, Singapore |
More Information
No publications provided
| Responsible Party: | Prof. Lee Bee Wah, National University Hospital, Singapore |
| ClinicalTrials.gov Identifier: | NCT00713089 History of Changes |
| Other Study ID Numbers: | SQNB01 |
| Study First Received: | July 7, 2008 |
| Last Updated: | July 7, 2008 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Keywords provided by National University Hospital, Singapore:
|
Eczema Asthma Allergic rhinitis |
Singapore Indonesia Gastrointestinal Flora |
Additional relevant MeSH terms:
|
Asthma Eczema Rhinitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Dermatitis Skin Diseases Skin Diseases, Eczematous Nose Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013