Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318695
Status:
COMPLETED
Last Update Posted:
2009-01-22
First Post:
2006-04-26
Brief Title:
Influence of Probiotics on Prevention of Atopy Atopic Disease and Immunological Responses
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Influence of Probiotics on Prevention of Atopy Atopic Disease and Immunological Responses- A Randomized Double-Blind Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None