A Randomized, Double Blind, Placebo-controlled Study to Investigate the Effect of Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 17938) on Symptoms of Viral Upper Respiratory Tract Infections in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Time to healing, defined as number of hours until absence of symptoms (fever, runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) as well as absence of use of Non-steroidal anti-inflammatory drugs (NSAIDs)
研究概览
简要总结
This study investigates the effect of Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) on symptoms of viral upper-respiratory tract infections in children.
详细描述
Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) have been shown to significantly reduce the number of febrile days and pain severity in upper respiratory tract infections in children aged six months to 5 years. The investigator's planned study complements this earlier publication by significantly increasing the number of cases and expanding the age range studied including children from 4 to 17 years of age diagnosed with viral upper respiratory-tract infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with symptoms of upper respiratory tract infection (coughing/fever/sneezing/runny or congested nose/pharynx pain)
- •Any gender
- •Age from 4 years to 17 years
- •Signing a informed consent form by at least one parent, foster parent or guardian after patient information and by children aged over 6 years
- •Negative Strep test
排除标准
- •Use of antibiotics or probiotics in the 10 days prior to study enrolment
- •Use of a probiotic other than the test sample during the study
- •Eight or more otitis media within 12 months
- •Two or more bacterial sinusitis within 12 months
- •Two or more pneumonia episodes within 12 months
- •History of two or more invasive infections (meningitis, cellulitis, osteomyelitis, septicaemia)
- •Chronic diarrhea
- •Recurrent deep skin or organ abscesses
- •Persistent superficial candidiasis
- •Use of antibiotics for two months or more to treat respiratory infections within 12 months
- •Gastroesophageal reflux
- •Perennial (e.g., dust mite or mold) or current seasonal hay fever allergy
- •Primary or secondary ciliary dyskinesia
- •Congenital malformations of the respiratory tract
结局指标
主要结局
Time to healing, defined as number of hours until absence of symptoms (fever, runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) as well as absence of use of Non-steroidal anti-inflammatory drugs (NSAIDs)
时间窗: 10 days
次要结局
- Number of children receiving antibiotic treatment in each treatment group.(10 days)
- Days of absences from day care center/school.(10 days)
- Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired)(10 days)
- Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) recorded in a "Symptom Diary".(10 days)
- Duration of fever, defined as the total number of hours that the child has a core temperature >38oC measured twice per day.(10 days)
- Amount of NSAIDs used.(10 days)
- Total amount of days of antibiotic use during the study, reported during the whole duration of the study in a the "Symptom Diary".(10 days)
- Number of unplanned medical visits (other than "Visit 1 and 2").(10 days)
研究者
Milosevits Gergely
Principal Investigator
Szent Miklós Szolgálat Kft.