Studio Clinico Randomizzato in Doppio Cieco, Controllato Verso Placebo, a Gruppi Paralleli, Sull'efficacia Clinica Di Un Prodotto a Base Di Probiotici Nel Migliorare I Comuni Sintomi Da Raffreddamento E La Risposta Immunitaria in Adulti Sani - ImmunoCold 2021
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Cold symptoms evaluation
研究概览
简要总结
The study is a double-blind randomized clinical trial which aims to evaluate the efficacy of a multi strain probiotic in human adults in controlling and improving cold symptoms and inflammatory response
详细描述
Adult subjects (age 18-44) with a history of upper airways infection, will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 12 weeks. After that, a 6 weeks follow-up. The answers at: Common Cold Questionnarie (CCQ), Wisconsin Upper Respiratory Symptoms Survey-21 (WURSS-21) and quality of life score (SF-36) will be compared in the two groups. In addition, serological markers (blood count, lymphocyte subpopulation (B, T, T4, T8, NK), IFN-γ and IL-10 levels) will be evaluated over a 18 week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •people who:
- •are willing and capable of joining the study
- •are willing of not varying their routine (lifestyle, physical activity..) during the study
- •are willing of not varying their diet during the study
- •are willing of using only the testing product during the study
- •are willing of not using products that may interfere with the testing product
- •have not recently joined similar studies
- •have signed informed consent
排除标准
- •not filling the inclusion criteria
- •with suspected or confirmed sensibility to one or more product component
- •with chronic diseases (cardiovascular congenital diseases, hepatic diseases, renal disease, immunodeficiency)
- •undergoing antibiotic/pharmacological treatment
- •with other concomitant disease (infective, respiratory, gastrointestinal, immune)
- •who underwent an immunomodulating treatment in the past 4 weeks
- •who underwent an immunosuppressant therapy in the past 3 months
- •with severe disease ongoing
- •who abuse of alcohol and/or drugs
- •who are considered not eligible by the investigator
- •not able to communicate due to language barriers, mental issues or cerebral functioning impairment
结局指标
主要结局
Cold symptoms evaluation
时间窗: 18 weeks
Cold symptoms will be evaluated before and after treatment through Common Cold Questionnaire(CCQ). Highest score: 27, Lowest 0. Higher scores indicate worst symptoms
次要结局
- Change of Wisconsin Upper Respiratory Symptoms Survey (WURSS-21)(18 weeks)
- Change of Short Form Health Survey 36 (SF-36)(18 weeks)
- Inflammatory status(18 weeks)
研究者
Giacomo Caio
Professor
Università degli Studi di Ferrara