Asthma Occupational Clinical Trial
Official title:
The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers: A Randomized Controlled Trial.
This project will be test the effect of probiotics on occupational allergic sensitization, respiratory symptoms and bronchial hyperresponsiveness in workers or students that develop respiratory symptoms exposed to laboratory animals, i.e., small rodents.
INTRODUCTION: The objective of the present project is to test the effect of probiotics on
occupational allergic sensitization, respiratory symptoms and bronchial hyperresponsiveness
in workers or students exposed to laboratory animals, i.e., small rodents.
Furthermore, our study aims to determine changes in immunological patterns with the use of
probiotics in adulthood, which could prevent allergic sensitization and allergic diseases.
Probiotics have been used as treatment in various allergic diseases, especially as
prevention of child atopic dermatitis by using them during pregnancy, or for neonates and
infants.
STUDY DESIGN AND METHODS: This will be a randomized controlled trial involving laboratory
animal workers and students exposed to rats, mice, hamsters, guinea pigs or rabbits.
Subjects will be recruited in the laboratories of the University of S. Paulo and State
University of Campinas (Unicamp). Exposed subjects will be randomly allocated to two groups:
treatment and placebo. Both groups will be followed up for two years. Subjects will be
evaluated at baseline, after one year and after two years.
Treatment: the intervention group will receive once daily capsules containing 109 CFU of
Lactobacillus rhamnosus HN001, Lactobacillus paracasei Lpc-37 and Bifidobacterium animalis
ssp. Lactis HN019 and the control group will receive once daily similar capsules containing
placebo.
Procedures: blood sampling for blood cell counts, measurement of total IgE levels, specific
immunoglobulin E (IgE) for rats, mice, hamsters, guinea pigs and rabbits; stool samples to
test for parasites and for probiotic bacteria; skin prick test for animal allergens and
common allergens, i.e. cockroaches, house dust mites, cats, dogs and mixed fungi;
spirometry; and evaluation of bronchial responsiveness by bronchial challenge tests if the
participant develop respiratory symptoms.
At the end of two years, changes in sensitization, bronchial responsiveness or symptoms in
the treatment group compared to the placebo group will be considered the effect of
probiotics.
Data analysis: group results will be compared by the chi-squared test regarding the
prevalence of sensitization and other categorical variables. For continuous variables such
as IgE levels, comparisons will be made by Student's t test. These analyses will be
performed at the 1- and 2-year time points.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention