Effetto Della Supplementazione di Una Miscela di Ceppi Probiotici (Bifidobacterium Breve M-16V, Bifidobacterium Lactis HN019, Lactobacillus Rhamnosus HN001) in Bambini Febbrili Con Infezioni Delle Alte Vie Respiratorie
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Mean duration of fever in days by measuring body temperature
研究概览
简要总结
The goal of this randomized non-pharmacological Intervention study is to evaluate the effects of probiotic supplements (Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, Lactobacillus rhamnosus HN001) on children affected by upper respiratory tract infections.
The main questions it aims to answer are:
- probiotic formulation can reduce intensity and duration of fever in children affected by upper respiratory tract infections
- probiotic formulation can influence the gut microbiota composition in children affected by upper respiratory tract infections
Participants will be asked to take probiotic supplements or placebo for 14 days and to collect three fecal samples: before probiotic supplementation (T0), 14 days after probiotic supplementation (T1), and 12 months after the enrollment (T2).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 29 Days 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Access to the Emergency room with fever and upper respiratory tract infection
- •Age > 28 days and ≤ 4 years
- •Signature of informed consent by parents or guardian
排除标准
- •Presence of pathologies associated with immunosuppression or ongoing immunosuppressant treatments
- •Hospitalisation/hospitalisation
- •Diarrhea at enrollment
- •No signed informed consent
结局指标
主要结局
Mean duration of fever in days by measuring body temperature
时间窗: Approximatively 7 days
To assess the effects of a probiotic supplement compaerd to a placebo on mean duration and intensity of fever measured by a thermometer
次要结局
- Adverse events(Approximatively 15 days)
- Gastrointestinal symptoms(Approximatively 7 days)
- Mean change in gut microbial composition by measuring gut microbiota characterization in fecal samples(1 year)
研究者
Cristiana Berti
Researcher
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico