Probiotics in the Prevention of Antibiotic Induced Diarrhea and Clostridium Difficile Associated Diarrhea; A Randomized Double Blind Placebo Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Occurrence of an antibiotic-associated diarrhea.
研究概览
简要总结
The objective of this study is to determine the efficacy of probiotics containing 25Bn (billion) CFU (colony-forming unit) of Lactobacillus rhamnosus, Sacchromyces boulardii and Bifidobacterium breve in the prevention of antibiotic induced diarrhea and Clostridium difficile diarrhea.
The chosen population consists of 190 hospitalized patients taking antibiotics. Preselected and randomized patients will take probiotics once daily until 1 week after the course of antibiotic is over or a placebo with 0 CFU.
The primary outcome is to detect the occurrence of an antibiotic-associated diarrhea. The secondary outcome is to assess the presence of Clostridium difficile toxins in stool culture.
详细描述
Antibiotic-associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) are a common nosocomial complication following antibiotic use. AAD and CDAD are most importantly associated with an increase in morbidity and mortality -especially in the elderly population- thus also contributing to a significant financial burden.
It was reported that 5-25% of patients on antibiotics will develop an AAD of which 10-20% are caused by Clostridium difficile. Furthermore, the widespread use of broad spectrum antibiotics is contributing to the increased incidence of CDAD.
The adult human intestinal tract contains up to 100 trillion micro-organisms. This microbiota is essential and injury to this barrier can result in multiple GI diseases such as infection by pathogens.
Probiotics are defined as "live micro-organisms which when administered in adequate amounts confer a health benefit on the host" [WHO 2007]. Many studies suggest that the use of probiotics and probiotic containing milks will significantly decrease the risk of AAD and maybe even CDAD.
This study is a randomized double-blind, placebo controlled trial using probiotics containing 25 Bn (billion) CFU of which: 5Bn CFU Lactobacillus rhamnosus, 5Bn CFU Sacchromyces boulardii, 5Bn CFU Bifidobacterium breve, 4.5Bn CFU Bifidobacterium lactis, 2.5 Bn CFU Lactobacillus acidophilus, 2.5Bn CFU Lactobacillus plantarum and 500Mn (million) CFU Lactobacillus reuters or a placebo containing 0 CFU in order to assess the role of probiotics in the prevention of AAD and CDAD.
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)
盲法说明
The randomization will be taken care of by the hospital pharmacy which will not be in contact with the patient.
The intern/resident who will recruit a patient in the study will not be in direct contact with the pharmacy.
The order will be sent to the pharmacy which, following a randomization sheet, will then send a neutral box containing a probiotic or a placebo product.
Only once the trial comes to an end, the investigator will receive from the pharmacy the randomization sheet and will then know which patient was given a probiotic and which was given a placebo regimen.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients hospitalized on antibiotics (single or multiple; oral or IV) assuming that they are able to eat/drink so that they can take the pills.
- •Regimen started within 48 hours of first course of antibiotics.
- •Able to sign a consent form.
排除标准
- •diarrhea on admission; bowel pathology that could result in diarrhea (eg. IBD), bowel surgeries and pouches; immunocompromised state (including febrile aplasia, immunosuppressive therapy, ICU patients, HIV-positive patients and renal transplant patients); prosthetic heart valves or history of endocarditis and rheumatic heart disease; use of metronidazole, vancomycin or fidaxomycin prior to stool culture for Clostridium difficile toxins.
结局指标
主要结局
Occurrence of an antibiotic-associated diarrhea.
时间窗: From the first day of inclusion in the trial up to a month after the antibiotic regimen is stopped.
Diarrhea is defined as more than two liquid stools for a period greater than 3 days and which is considered by the patient as an increase in stool quantity compared to regular basis, evaluated in a patient on antibiotics.
次要结局
- Presence of Clostridium difficile toxins in stool culture.(Upon eventual onset of diarrhea, from the first day of inclusion in the trial and up to a month after the antibiotic regimen is stopped; in hospitalized patients only.)
研究者
Yara El Helou
Medical Student
Saint-Joseph University