Clinical trial NCT00713089: Study of Stool Microbiota in Two Diverse Cohorts of Asian and Its Influence on Allergy Development
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eczema
Asthma
Allergic Rhinitis
Keywords: Eczema
Asthma
Allergic rhinitis
Singapore
Indonesia
Gastrointestinal Flora
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Gadjah Mada University
First posted: 2008-07-11
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Incidence of allergies of eczema, asthma and allergic rhinitis in 2 diverse cohorts (Singaporean and Indonesian)
timeFrame: 2 years
Secondary outcomes:
measure: Gastrointestinal flora in Singapore and Indonesia cohorts
timeFrame: 1 year
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Gadjah Mada University Hospital
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Bee Wah Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: