Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200954
Status:
COMPLETED
Last Update Posted:
2008-08-18
First Post:
2005-09-12
Brief Title:
Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics
Sponsor:
The Netherlands Asthma Foundation
Organization:
The Netherlands Asthma Foundation
Study Overview
Official Title:
Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics
Status:
COMPLETED
Status Verified Date:
2007-05
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:
Administration of probiotics to pregnant women from an atopic family and subsequently to their high-risk newborns results in prevention of the incidence or in a decrease of the severity of atopic disease during infancy
Detailed Description:
Background Atopic diseases are increasing in countries with a Western lifestyle The hygiene hypothesis states that the increase in atopic disease could be due to reduced exposure to microbial antigens in early in life In search of new preventive therapies for atopic disease exposure of pregnant women with previous or recent atopic disease and their offspring to probiotics has been suggested Probiotics are mono or mixed cultures of microbes which when applied to animal or man can beneficially affect the host among others by inducing an immune response Probiotics are generally accepted to be safe in children Probiotics have shown to be effective in primary prevention of atopic disease in high-risk neonates in one study so far However it is still unclear by what mechanism probiotics work and which is the most immunopotent combinations of probiotics It is likely that antigen-presenting cells APCs are involved since these cells are important in the first line of defence in the gastrointestinal tract It can be imagined that the immune response is the result of the interplay between probiotics and APCs In particular the match between pathogen-associated molecular patterns PAMPs on probiotics and their counterparts on APCs the pathogen-recognition-receptors PRRs like for instance Toll-like receptors is decisive in this aspect
Hypothesis Administration of probiotics to pregnant women and their offspring may reduce the development of sensitization as well as the onset of atopic disease in their offspring
Aim To study the effect of probiotics on sensitisation and the prevalence of atopic disease the severity of atopic disease the intestinal flora and immune parameters in high-risk newborns
Methods To study this hypothesis a randomised double-blind placebo-controlled trial will be carried out by administration of probiotics to pregnant women with previous or recent atopic disease as well as to their offspring Primary outcome parameters are firstly the prevalence and severity of sensitization and atopic disease in the offspring during a follow-up of two years Secondary outcome parameters are the change in stool composition during treatment with probiotics and in-vitro production of cytokines by PBMCs collected at 3 months 1 year and 2 years of age
Expected results Perinatal administration of probiotics to pregnant women and their offspring may hamper the development of sensitization and atopic disease in their offspring This may be due to modulation of the intestinal microbiota composition and modulation of the developing immune system
Hypothesis Administration of probiotics to pregnant women and their offspring may reduce the development of sensitization as well as the onset of atopic disease in their offspring
Aim To study the effect of probiotics on sensitisation and the prevalence of atopic disease the severity of atopic disease the intestinal flora and immune parameters in high-risk newborns
Methods To study this hypothesis a randomised double-blind placebo-controlled trial will be carried out by administration of probiotics to pregnant women with previous or recent atopic disease as well as to their offspring Primary outcome parameters are firstly the prevalence and severity of sensitization and atopic disease in the offspring during a follow-up of two years Secondary outcome parameters are the change in stool composition during treatment with probiotics and in-vitro production of cytokines by PBMCs collected at 3 months 1 year and 2 years of age
Expected results Perinatal administration of probiotics to pregnant women and their offspring may hamper the development of sensitization and atopic disease in their offspring This may be due to modulation of the intestinal microbiota composition and modulation of the developing immune system
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