The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers: A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- detection the reduction of sensitization in workers exposed to laboratory animal
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Probiotic Formula (Drug)
Placebo Oral Capsule
The control group will receive once daily similar capsules containing placebo.
干预措施: Placebo Oral Capsule (Other)
结局指标
主要结局
detection the reduction of sensitization in workers exposed to laboratory animal
时间窗: 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.
次要结局
- Assessment of symptoms(two years)
研究者
Elcio Vianna
Principal Investigator
University of Sao Paulo