Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113659
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2005-06-09
Brief Title:
Use of a Probiotic Supplement to Prevent Asthma in Infants
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Trial of Infant Probiotic Supplementation to Prevent Asthma
Status:
COMPLETED
Status Verified Date:
2024-06
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:
The goal of the study is to understand the mechanisms of how antigen presentation affects the developing immune system and subsequently affects susceptibility to or protects against asthma development This randomized controlled study will test the effectiveness of daily supplementation of Lactobacillus GG for the first 6 months of life on the early immunological development of asthma
Detailed Description:
BACKGROUND
During infancy environmental factors may affect immune system development and lead to the development of asthma The hygiene hypothesis suggests that the absence of endotoxin exposure leads to an unfavorable Th1Th2 balance Thus a controlled antigen exposure during infancy may establish a Th1Th2 balance that blocks the onset of asthma or slows the progression of the disease
Lactobacillus is a bacterium commonly found in many foods eg yogurt in the typical childhood diet It is also used as a probiotic supplement to prevent the development of diarrhea Due to its safety and availability Lactobacillus is an ideal bacterium to use as an antigen exposure to test the hygiene hypothesis
Consistent with the hygiene hypothesis observational studies suggest that early Lactobacillus exposure leads to decreased risk of developing atopic dermatitis which has been associated with asthma in later years The investigators are aware of no study that has examined the effect of Lactobacillus on the development of early markers of asthma in children at risk for developing the disease They hypothesize that Lactobacillus can be used as an antigen exposure to establish a Th1Th2 balance that blocks the development of early markers of asthma
DESIGN NARRATIVE
The hygiene hypothesis suggests that the absence of endotoxin exposure leads to an unfavorable Th1Th2 balance A controlled antigen exposure during infancy may help establish a Th1 Th2 balance that blocks the onset or progression of asthma Lactobacillus is a bacterium found in many foods in the typical pediatric diet and is used as a supplement to prevent diarrhea Due to the safety feasibility and early promising results in preventing atopic dermatitis Lactobacillus is an ideal bacterium to use as an exposure to test the hygiene hypothesis The investigators hypothesize that such an exposure may block or delay development of early markers of asthma
The study will use a randomized placebo-controlled trial design to measure the effect of a 6-month daily exposure of Lactobacillus as an infant supplement on immune system and asthma development during the first 3 years of life
The study will measure the effect of the antigen exposure on the presence and time to presentation of 1 early clinical markers for asthma development frequent wheezing wheezing without colds rhinitis and atopic dermatitis 2 early immunologic markers for asthma development eosinophilia immunoglobulin E and 3 development of a T-helper phenotype Th-1 vs Th-2 Investigators will characterize the Th phenotype by measuring the whole blood lymphocyte response to stimulants focusing on Th1 IFN-gamma interleukin IL-12 and Th2 cytokines IL-10 IL-4 IL-13 as well as real-time reverse transcriptase polymerase chain reaction RT-PCR with PCR amplification TaqMan to quantify RNA transcripts Clinical and immunologic markers will be measured up to 3 years of age
Adherence will be assessed using diaries pill count and Lactobacillus stool cultures
The study will use intention-to-treat analysis and will control for the impact of family environmental diet and demographic factors on outcomes using multivariate regression and survival analysis techniques Investigators expect that when compared to controls subjects receiving Lactobacillus will have decreased and delayed development of markers for asthma and a greater likelihood of developing a Th1 phenotype
During infancy environmental factors may affect immune system development and lead to the development of asthma The hygiene hypothesis suggests that the absence of endotoxin exposure leads to an unfavorable Th1Th2 balance Thus a controlled antigen exposure during infancy may establish a Th1Th2 balance that blocks the onset of asthma or slows the progression of the disease
Lactobacillus is a bacterium commonly found in many foods eg yogurt in the typical childhood diet It is also used as a probiotic supplement to prevent the development of diarrhea Due to its safety and availability Lactobacillus is an ideal bacterium to use as an antigen exposure to test the hygiene hypothesis
Consistent with the hygiene hypothesis observational studies suggest that early Lactobacillus exposure leads to decreased risk of developing atopic dermatitis which has been associated with asthma in later years The investigators are aware of no study that has examined the effect of Lactobacillus on the development of early markers of asthma in children at risk for developing the disease They hypothesize that Lactobacillus can be used as an antigen exposure to establish a Th1Th2 balance that blocks the development of early markers of asthma
DESIGN NARRATIVE
The hygiene hypothesis suggests that the absence of endotoxin exposure leads to an unfavorable Th1Th2 balance A controlled antigen exposure during infancy may help establish a Th1 Th2 balance that blocks the onset or progression of asthma Lactobacillus is a bacterium found in many foods in the typical pediatric diet and is used as a supplement to prevent diarrhea Due to the safety feasibility and early promising results in preventing atopic dermatitis Lactobacillus is an ideal bacterium to use as an exposure to test the hygiene hypothesis The investigators hypothesize that such an exposure may block or delay development of early markers of asthma
The study will use a randomized placebo-controlled trial design to measure the effect of a 6-month daily exposure of Lactobacillus as an infant supplement on immune system and asthma development during the first 3 years of life
The study will measure the effect of the antigen exposure on the presence and time to presentation of 1 early clinical markers for asthma development frequent wheezing wheezing without colds rhinitis and atopic dermatitis 2 early immunologic markers for asthma development eosinophilia immunoglobulin E and 3 development of a T-helper phenotype Th-1 vs Th-2 Investigators will characterize the Th phenotype by measuring the whole blood lymphocyte response to stimulants focusing on Th1 IFN-gamma interleukin IL-12 and Th2 cytokines IL-10 IL-4 IL-13 as well as real-time reverse transcriptase polymerase chain reaction RT-PCR with PCR amplification TaqMan to quantify RNA transcripts Clinical and immunologic markers will be measured up to 3 years of age
Adherence will be assessed using diaries pill count and Lactobacillus stool cultures
The study will use intention-to-treat analysis and will control for the impact of family environmental diet and demographic factors on outcomes using multivariate regression and survival analysis techniques Investigators expect that when compared to controls subjects receiving Lactobacillus will have decreased and delayed development of markers for asthma and a greater likelihood of developing a Th1 phenotype
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL080074 | NIH | None | httpsreporternihgovquickSearchR01HL080074 |