Trial of Infant Probiotic Supplementation to Prevent Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Montefiore Medical Center
- Enrollment
- 203
- Locations
- 1
- Primary Endpoint
- Development of atopic dermatitis
Study Overview
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 Th1/Th2 balance. Thus, a controlled antigen exposure during infancy may establish a Th1/Th2 balance that blocks the onset of asthma or slows the progression of the disease.
Lactobacillus is a bacterium commonly found in many foods (e.g., 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 Th1/Th2 balance that blocks the development of early markers of asthma.
DESIGN NARRATIVE:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 4 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Expectant parents either of whom have a history of asthma
- •Parents willing to add a probiotic supplement or placebo to one feeding each day for 6 months
Exclusion Criteria
- •A sibling currently or previously enrolled in the study
- •Any major congenital birth deformities, acute illness at enrollment, or chronic conditions affecting food intake or metabolism
- •Participation in another clinical study
- •Infants from multiple gestation births (since only one child per family will be included in the study, incorporating a child from a multiple birth would add unnecessary burden to parents by requiring them to administer different formulas to different children)
Arms & Interventions
2
Participants in this arm will receive a placebo.
Intervention: Placebo (Dietary Supplement)
1
Participants in this arm will receive Lactobacillus GG.
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
Development of atopic dermatitis
Time Frame: Measured from birth to 3 years of age
Secondary Outcomes
- Early clinical markers of asthma, including frequent wheezing, wheezing without upper or lower respiratory tract infections, allergic rhinitis, atopic dermatitis, serum IgE, and eosinophilia(Measured from birth to 3 years of age)