Status:
COMPLETED
Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
National Medical Research Council (NMRC), Singapore
National University of Singapore
Conditions:
Eczema
Asthma
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This will be a double-blind, randomized placebo-controlled study. 253 children were recruited and randomly assigned into one of 2 groups to receive either normal infant formula or formula with Bifidob...
Detailed Description
One of the most important early influences on the immune system is the intestinal microflora. The gastrointestinal tract, being the largest body area interacting with the environment, is one of the ea...
Eligibility Criteria
Inclusion
- Parents agree to the subject's participation in the study and informed consent has been obtained.
- Either parent or sibling (i.e. 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 to any of a panel of common allergens.
- The subject is born at above 35 weeks of gestation and weighs above 2 kg.
- The subject does not have major congenital malformations/major illness.
- Family appears to be able to successfully complete this trial.
Exclusion
- Mother has a medical illness, which in the opinion of the investigator, will interfere with the results of the study.
- The parent is unable/unwilling to comply with procedures.
- The parents choose to totally breast-feed the child.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00318695
Start Date
May 1 2004
End Date
January 1 2009
Last Update
January 22 2009
Active Locations (1)
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1
National University Hospital (NUH)
Singapore, Singapore, 119074