Probiotics in Hospitalized Patients Study
关键词
抽象
日期
| 最后验证: | 10/31/2014 |
| 首次提交: | 05/07/2012 |
| 提交的预估入学人数: | 05/08/2012 |
| 首次发布: | 05/09/2012 |
| 上次提交的更新: | 11/16/2014 |
| 最近更新发布: | 11/17/2014 |
状况或疾病
干预/治疗
Dietary Supplement: Go Live
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: Placebo BID | |
| Active Comparator: Go Live Rx Probiotic BID |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 18 years of age or older admitted to SSH and prescribed antibiotics for an expected duration >3 days (may include patients on antibiotics prior to admission). Exclusion Criteria: - 1. History of chronic diarrhea illness (Irritable Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease, Chronic pancreatitis 2. Diarrhea at screening 3. Active Colitis of any etiology 4. History of colectomy 5. Regular consumption of probiotics within 72 hours 6. Unable to provide written consent 7. History of or active pancreatitis 8. Severe Sepsis or Septic Shock (sepsis with end organ failure e.g. renal failure, ARDS, MS changes and or meets criteria by n ational guideline, and or requiring vasopressors) 9. Hypersensitivity to any ingredient in probiotic product 10. Severe Immunosuppression (ANC <1000, AIDS/CD4 count <200 cells, cancer on active chemothereapy, h/o of solid or bone marrow transplant) 12. Acute burn injuries |
结果
主要结果指标
1. Incidence of Clostridium difficle associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo [60 days after hospitalization]
次要成果指标
1. Incidence of Antibiotic associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo [60 Days after hospitalization]
