A Pilot Study; a Randomized Double-blind Placebo-controlled Study to Investigate a Probiotic Supplement on Symptoms of Upper Respiratory Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- BioGaia AB
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of episodes
研究概览
简要总结
This randomized, double-blind, placebo-controlled pilot study will evaluate the effect of a probiotic supplement on upper respiratory tract infections (URTIs) in children aged 4-18 years with a history of recurrent URTIs. Participants will be randomized to receive either probiotic drops or placebo drops. The primary objective is to assess the effect of the probiotic on the frequency of URTI episodes during the study period. Secondary objectives include evaluation of respiratory symptoms, medication use, healthcare visits, school absenteeism, recovery of the administered probiotic, and safety.
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
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 4 to18 years
- •Male or female
- •Healthy (no known chronic disease)
- •At least 3 episodes of Upper Respiratory Tract Infection (pharyngitis and or tonsillitis, cold, rhinitis, sinusitis) in the previous year
- •Written informed consent signed by both parents or caregivers
排除标准
- •Use of antibiotics or probiotic products 2 weeks prior inclusion in the study
- •Use of two or more consecutive months on antibiotics for respiratory infections on the last year
- •Participation in another clinical trial
- •Parents or caregivers unable to read, understand and follow the instructions
研究组 & 干预措施
Placebo
Placebo drops
干预措施: Placebo (Other)
Probiotic
Probiotic drops
干预措施: Probiotic (Other)
结局指标
主要结局
Number of episodes
时间窗: 3 months
Number of episodes presenting with three out of four of the following symptoms for three consecutive days: Fever, sore throat, nasal congestion or runny nose.
次要结局
未报告次要终点