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

This study has been completed.
Sponsor:
Collaborator:
Gadjah Mada University
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00713089
First received: July 7, 2008
Last updated: January 7, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 74
Study Start Date: March 2006
Study Completion Date: November 2009
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
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713089

Locations
Indonesia
Gadjah Mada University Hospital
Yogyakarta, Indonesia, 55281
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Gadjah Mada University
Investigators
Principal Investigator: Bee Wah Lee, MD National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00713089     History of Changes
Other Study ID Numbers: SQNB01
Study First Received: July 7, 2008
Last Updated: January 7, 2014
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:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014