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

7. januar 2014 opdateret af: National University Hospital, Singapore

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Indonesien
- - Yogyakarta, Indonesien, 55281
    - Gadjah Mada University Hospital
Singapore
- - Singapore, Singapore, 119074
    - National University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Incidence of allergies of eczema, asthma and allergic rhinitis in 2 diverse cohorts (Singaporean and Indonesian) Tidsramme: 2 years	2 years

Sekundære resultatmål

Resultatmål	Tidsramme
Gastrointestinal flora in Singapore and Indonesia cohorts Tidsramme: 1 year	1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National University Hospital, Singapore

Samarbejdspartnere

Gadjah Mada University

Efterforskere

Ledende efterforsker: Bee Wah Lee, MD, National University Hospital, Singapore

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2006

Primær færdiggørelse (Faktiske)

1. november 2009

Studieafslutning (Faktiske)