Clinical Trial: The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers: A Randomized Controlled Trial.

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 Summary:

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. cockroa
Sponsor: University of Sao Paulo

Current Primary Outcome: detection the reduction of sensitization in workers exposed to laboratory animal [ Time Frame: two years ]

To compare the effect of the oral administration of probiotics on the development of occupational sensitization to the effect of a placebo. Sensitization will be assessed by prick test and specific IgE.


Original Primary Outcome: Same as current

Current Secondary Outcome: Assessment of symptoms [ Time Frame: two years ]

All subjects will respond to the respiratory symptoms questionnaire of the European Community Respiratory Health Survey (ECRHS), translated and validated by Ribeiro et al. (2007). In addition, both groups will respond to a questionnaire about symptoms of allergic rhinitis, asthma and allergic skin disease, previous exposure to laboratory animals, a personal and family history of allergic diseases, as well as gastrointestinal, urinary and infectious symptoms


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: January 11, 2017
Date Started: January 2017
Date Completion: January 2020
Last Updated: January 11, 2017
Last Verified: January 2017