Probiotics in the Reduction of Antibiotic Associated Diarrhea and Clostridium Difficile in Pneumonia Patients Within a Community Teaching Hospital
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Antibiotic Associated Diarrhea
研究概览
简要总结
The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients.
详细描述
The study will include patients admitted to Good Samariatan Hospital and placed on the pneumonia order set. After obtaining consent, subjects will be randomized to the proboiotic or placebo group. Subjects will be followed for 21 days after starting the study treatment to determine critical outcomes such as incidence of antibiotic-associated diarrhea and C-Diff. Other outcomes include length of stay, healthcare costs, and death.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to Good Samaritan Hospital
- •Placed on pneumonia order set
排除标准
- •Patient with inadequate coherency to understand consent
- •Active Diarrhea at admission
- •Non-controlled intestinal disease
- •Documented positive C. difficile infection within the 3 months before enrollment
- •Antibiotic use at hospital admission
- •Immunosuppressive therapy
- •Pregnancy
- •Allergic to ingredients in Florajen-3
- •Allergic to ingredients in placebo
- •Immunocompromised state including:
- •HIV with a low CD4 count
- •Active malignancy receiving chemotherapy
- •Medications including long-term steroids (>2 weeks), and disease modifying biologic agents
- •Acquired immune deficiency
- •Unable to take oral medication
- •Less than 4 doses of probiotic or placebo
- •Taking probiotic in the past 30 days
研究组 & 干预措施
Probiotic
Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The treatment is Florajen-3. The ingredients in Florajen-3 are:
Lactobacillus acidophilus-over 7.5 billion Bifidobacterium lactis-over 6.0 billion Bifidobacterium longum-over 1.5 billion
干预措施: Florajen-3 (Dietary Supplement)
Placebo
Placebo will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The ingredients in the placebo are:
Rice maltodextrin
干预措施: Placebo (Other)
结局指标
主要结局
Antibiotic Associated Diarrhea
时间窗: 21 days after starting study treatment
Subjects will be asked to keep a diary for 20 days after starting study treatment and will be contacted by a nurse approximately 21 days after starting study treatment
次要结局
- Length of stay(during hospitalization up to 4 weeks)
- Mortality(During hospitalization up to 4 weeks)
- Healthcare costs(During hospitalization up to 4 weeks)
- Clostridium difficile(21 days after initiating study treatment)
研究者
Jenni Steinbrunner
Research Specialist
TriHealth Inc.