The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03021161
• Date of registration: 11/01/2017
• Prospective Registration: No
• Primary sponsor: University of Sao Paulo
• Public title: The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers prob&asthma
• Scientific title: The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers: A Randomized Controlled Trial.
• Date of first enrolment: January 2017
• Target sample size: 200
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03021161
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Brazil

Contacts

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

• Name: Elcio O Vianna, MD, PHD

• Name: Elcio O Vianna, MD, PHD

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Asthma Occupational

Intervention(s)

Other: Placebo Oral Capsule

Drug: Probiotic Formula

Primary Outcome(s)

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

Secondary Outcome(s)

Assessment of symptoms [Time Frame: two years]

Secondary ID(s)

548/2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Sao Paulo General Hospital