Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-06-14 @ 1:05 AM
Study NCT ID:
NCT03021161
Status:
UNKNOWN
Last Update Posted:
2017-01-13
First Post:
2017-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers: A Randomized Controlled Trial.
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
NOT_YET_RECRUITING
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:
prob&asthma
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
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?: