Efficacy and Safety of the Probiotic Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile Related Infections in Hospitalized Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- diarrhea
研究概览
简要总结
The purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center. They will be randomly assigned to an intervention group receiving L. reuteri or a placebo. Supplementation will occur during antibiotic treatment and for an additional 7 days after cessation of treatment. Data collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation, and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI symptoms.
详细描述
The data being measured for this study include:
Primary outcome = incidence of diarrhea during and after treatment with antibiotics. An episode of diarrhea is defined as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return, which must be at least 48 hours later.
Secondary variables:
- severity of diarrhea measured as the discrete period between the time when stool output meets or exceeds 3 soft and unformed or watery bowel movements to the time when formed stools return.
- frequency of stool samples positive for C. Difficile toxin A or B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post-antibiotic-treatment to detect possible clearance of C. Difficile, in patients ingesting L. reuteri versus placebo.
- frequencies of other gastrointestinal symptoms at 1, 2, and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated Gastrointestinal Symptom Rating Score.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving antibiotics for not more than 48 hours prior to enrollment and free from diarrhea
- •able to understand and sign informed consent and HIPPA
- •available throughout the study period
- •subjects should have the mental ability to understand and willingness to fulfill 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
- •NPO without PO meds
- •neutropenia (an absolute neutrophil count (ANC) of less than 1500/microL)
- •HIV positive with a CD4+ T-lymphocyte count <400 per mcL blood
- •requiring care in an intensive care unit
- •status-post bowel resection during hospitalization
- •patient's receiving antibiotics four weeks prior to hospitalization
- •patient with severe life threatening illness or immunocompromised
- •pregnancy
研究组 & 干预措施
Identical Placebo
干预措施: Lactobacillus reuteri (Dietary Supplement)
L. reuteri
干预措施: Lactobacillus reuteri (Dietary Supplement)
结局指标
主要结局
diarrhea
时间窗: 28+ days
Instances of diarrhea
次要结局
- Severity of diarrhea(28+ days)
- Frequency of stool samples positive for C. difficile toxin A and B(baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days)
- Frequencies of other gastrointestinal symptoms(1, 2 and 4 weeks)
研究者
Alison Steiber
Adjunct profession
Case Western Reserve University