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Sponsors and Collaborators: |
National University Hospital, Singapore National Medical Research Council (NMRC), Singapore National University, Singapore |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00318695 |
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 Bifidobacterium longum and Lactobacillus rhamnosus GG. The primary aim is to assess the effect of early administration (from birth) of probiotics on the incidence of allergic sensitization, eczema, asthma and rhinitis.
Condition | Intervention | Phase |
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Eczema Asthma Allergic Rhinitis |
Drug: Bifidobacterium longum Drug: Lactobacillus rhamnosus GG |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses- A Randomized Double-Blind Placebo Controlled Trial |
Estimated Enrollment: | 253 |
Study Start Date: | May 2004 |
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 earliest to be colonized and is quantitatively the most important source of microbial stimulation for the immature immune system. Probiotics are helpful bacteria from healthy intestinal tract, and have shown potential in reducing allergy. This is extremely important as allergic diseases are on the rise worldwide. Probiotics are safe, easy to administer and can be used early for intervention as allergic sensitization, once established, is difficult to reverse.
This double-blind, randomized placebo-controlled study has recruited 253 children from birth. These babies, with a family history of atopic disease, will be randomly assigned into one of 2 groups to receive either normal infant formula or formula with Bifidobacterium longum and Lactobacillus rhamnosus GG. The formula will be consumed postnatally for 6 months, after which the child will continue with normal follow-on milk. Children will be examined at the neonatal period and at 1, 3, 6, 12 and 24 months. Blood samples will be collected at birth (cord blood) and at 1 year of age. Blood will be analyzed for cytokines, total IgE and specific IgE. Skin prick test for common allergens will also be performed at 1 year of age. Stools will be collected at 5 days, 1, 3, 12 months and analyzed for the pattern of stool colonization.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Singapore | |
National University Hospital (NUH) | |
Singapore, Singapore, 119074 |
Principal Investigator: | Dr Lynette Shek, Consultant | National University Hospital (NUH), Singapore |
Study ID Numbers: | SQNU01 |
Study First Received: | April 26, 2006 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00318695 |
Health Authority: | Singapore: Domain Specific Review Boards |
Probiotics Eczema Asthma |
Allergic Rhinitis Prevention Immunological responses |
Otorhinolaryngologic Diseases Skin Diseases Asthma Rhinitis Eczema Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases Sulfalene Hypersensitivity, Immediate Skin Diseases, Eczematous Respiratory Hypersensitivity Dermatitis |
Immune System Diseases Bronchial Diseases Nose Diseases |