Evaluation of the Immunomodulation Effect of ESIT12, a Poplar-type Propolis Dry Extract and Its Efficacy in Subjects At Risk of Contracting Upper Respiratory Tract Infections (URTIs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fytexia
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Supplementation Efficacy on URTI incidence
研究概览
简要总结
The aim of the present investigation is to evaluate the immunomodulation effect of ESIT12, a poplar-type propolis dry extract standardized in polyphenols, and its efficacy in subjects at risk of contracting upper respiratory tract infections (URTIs), during a 12-week supplementation period plus 4-week follow-up.
The number of onset of upper respiratory tract infections, the symptoms severity and lasting and interferences with well-being will be assessed with WURSS-24 questionnaire. The quality of life will be assessed with the SF-36 questionnaire and a testimonial. Blood immune markers will also be assessed. Finally, long lasting benefits will additionally be evaluated 4 weeks after end of the supplementation period. The design of the study is double-blind, randomized, parallel and placebo controlled.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •inactive or minimally active according to the IPAQ short form questionnaire
- •BMI 18,5-29,9
排除标准
- •Pregnant women, breastfeeding women, women positive at Beta-HCG serology test and who hope to become pregnant
- •Allergy to beehive products and known allergy (general)
- •Cystic fibrosis
- •Congenital or acquired immunodeficiency syndrome and disease
- •History of asthma (within prior 24 months) or chronic respiratory disease
- •Subjects who underwent medical treatment for COVID-19 within last 3 months
- •History of immune system disorder or auto-immune disorder
- •History of treated diabetes or treated hypertension
- •Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, and malignancies
- •Those considered unsuitable for the participation by the physician
- •No vaccination within 12 weeks prior to enrolling in the study
- •No antibiotics within 12 weeks prior to enrolling in the study
- •No anti-inflammatory drugs within 4 weeks prior to enrolling in the study
- •No steroids within 12 weeks prior to enrolling in the study
- •No immunological drugs within 4 weeks prior to enrolling in the study
- •No food/dietary supplements within 4 weeks prior to enrolling in the study
- •No current or recent participation in another clinical trial (within 30 days prior to screening)
结局指标
主要结局
Supplementation Efficacy on URTI incidence
时间窗: 12 weeks
The incidence of URTI developped in Verum compare to Placebo measured with the WURSS-24 symptoms questionnaire
Supplementation Efficacy on number of URTI incidence
时间窗: 12 weeks
The number of URTI incidence per person in Verum compare to Placebo measured with the WURSS-24 symptoms questionnaire
次要结局
- Supplementation Efficacy on URTI symptoms(12 weeks)
- Supplementation Efficacy on URTI severity(12 weeks)
- Supplementation Efficacy on immunomodulation(12 weeks)
- Supplementation Efficacy on impact of URTI on quality of life(12 weeks)