NCT05879393已完成不适用
The Effect of the Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People: A Randomised Controlled Trial
University Maribor2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2020年10月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Incidence of URTI
研究概览
简要总结
The goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic OMNi-BiOTiC® Active to shorten the incidence and duration of acute upper respiratory tract infections (URTIs) in older people. The main questions it aims to answer is:
- Is the multistrain probiotic OMNi-BiOTiC® Active effective in reducing the incidence of URTIs in older people?
- Is the multistrain probiotic OMNi-BiOTiC® Active effective in reducing the duration of URTIs in older people?
- Is the multistrain probiotic OMNiBiOTiC® Active effective in changing selected immunological blood parameters in older people? Researchers will compare the probiotic group and the placebo group to see if the incidence or duration of URTIs are significant among the groups.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years or older at the signing of the written consent form
- •ability of participant to eat independently
- •ability of participant to adhere to all procedures of the clinical study
排除标准
- •participants experienced an exacerbation of an existing chronic disease
- •participants experienced an exacerbation of metabolic diseases,
- •participants with mental incapacity to understand instructions
- •participants were prescribed long-term usage of antibiotics.
- •participants that changed their eating habits or consumed any probiotics 14 days
- •participants with markedly abnormal results of blood tests were excluded.
结局指标
主要结局
Incidence of URTI
时间窗: 12 weeks supplementation
Comparison of the incidence of acute upper respiratory tract infections among older people in both arms
次要结局
- Duration of URTI(12 weeks supplementation)
- Changes in concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils in serum(12 weeks supplementation)
- Changes in concentration of Immunoglobulin A (IgA) in serum(12 weeks supplementation)
研究者
Sabina Fijan
Assoc. prof. dr.
University Maribor
研究点 (2)
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