The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers (prob&asthma)

January 11, 2017 updated by: Elcio Vianna, University of Sao Paulo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil, 14048900
        • University Hospital of Ribeirao Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older than 18 years, both sexes, ability to read, understand and to decide on protocol consenting.
  • Participants should be healthy
  • Animal handling for research purposes as part of regular activities as a worker or student.
  • Planning to continue this activity for the next 2 years.

Exclusion Criteria:

  • Previous laboratory animal handling for 15 days or longer. This exposure may have sensitized or selected people that are not susceptible to sensitizations.
  • Sensitization to any laboratory animal (rat, mouse, hamster, guinea pig or rabbit).
  • Allergic diseases that interfere with the evaluation of study variables.
  • Using immunosuppressive drugs (ex: methotrexate, cyclosporine, leflunomide) or corticosteroids in immunosuppressive doses (e.g.: prednisone doses of 1.0 mg/kg/day or more).
  • Cancer or treatment of neoplasia.
  • Having diseases that cause immunosuppression such as diabetes, AIDS, renal failure, heart failure or other organ failure.
  • Pregnancy, breastfeeding, or not willing to take necessary precautions to avoid a pregnancy during the study.
  • Use of other probiotic products during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
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 (probiotic formula).
Drug: Probiotic Formula
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
Other Names:
  • L. rhamnosus, L. paracasei, B. Lactis
Placebo Comparator: Placebo Oral Capsule
The control group will receive once daily similar capsules containing placebo.
Other: Placebo Oral Capsule
Capsule containing no probiotic
Other Names:
  • Probiotic diluent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Elcio O Vianna, MD, PHD, University of S. Paulo Medical School of Rib. Preto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 548/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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