Efficacy of the Probiotic Lactobacillus Reuteri in Prevention of Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children and Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To assess if the probiotic L. reuteri is effective in preventing AAD in children
研究概览
简要总结
The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections in children and adolescents.
详细描述
Antibiotic-associated diarrhoea (AAD) occurs in up to 25% of all individuals receiving antibiotics (Bartlett, 2002). In hospitalized patients, AAD is related to significant increases in mortality, length of stay, and cost of medical care (McFarland, 2006). Twenty-nine percent of hospitalized patients may develop diarrhoea after antibiotic use; therefore, identifying strategies to minimize antibiotic-associated diarrhoea could be of significant medical and economic advantage (McFarland, 1998). A promising tool in this area is the probiotic Lactobacillus reuteri
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 - 18 years of age
- •Receiving antibiotics for not more than 48 hours prior to enrolment and free from diarrhoea
- •The signed informed consent by one/both parents / legal guardian and by the subject if she/he is 12 years or older
- •Available throughout the study period
- •No use of any other probiotic products during the study period (Bulgarian yoghurt without added probiotics can be used)
- •Subject or parents/guardian should have the mental ability to understand and willingness to fulfil all the details of the protocol
排除标准
- •Three or more soft and unformed or watery stools per day at admission
- •Receiving chemotherapy or radiation therapy
- •Diagnosis of inflammatory bowel disease
- •Enteral or parenteral nutrition only
- •Requiring care in an intensive care unit
- •Status post-bowel resection during hospitalization
- •Receiving antibiotics four weeks prior to hospitalization
- •Patient with severe life threatening illness or immunocompromised (HIV/AIDS, cancer, genetic disorders including cystic fibrosis, children with opportunistic infections, metabolic diseases)
- •Pregnancy
- •Lack of possibility to store the study product in a temperature below 25°C during the hot season of the year
结局指标
主要结局
To assess if the probiotic L. reuteri is effective in preventing AAD in children
时间窗: 2 years
Incidence of diarrhea during and after treatment with antibiotics in patients ingesting L. reuteri versus placebo during the study period, measured as mean number of episodes per patient. An episode of diarrhea is defined as three or more (≥ 3) soft and unformed or watery bowel movements per day for at least 48 hours.
次要结局
- Incidence of mild diarrhea and severity if diarrhea in children with probiotic treatment(2 years)
- Severity of diarrhoea in patients ingesting L. reuteri versus placebo(2 years)
- Frequency of stool samples positive for C. difficile toxin A and B(2 years)
- Frequencies of other gastrointestinal symptoms(2 years)
研究者
Miglena Georgieva
Assoc Prof Miglena Georgieva, MD, PhD, St Marina University Hospital, Varna, Bulgaria.
St Marina University Hospital, Varna, Bulgaria