Status:
COMPLETED
Use of a Probiotic Supplement to Prevent Asthma in Infants
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
1-4 years
Phase:
NA
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 developme...
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 le...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00113659
Start Date
June 1 2005
End Date
May 1 2014
Last Update
June 11 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco
San Francisco, California, United States, 94118