Probiotics for Reduction of Colonisation With Clostridium Difficile in Antibiotic Treated Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Region Skane
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Differences in emerging cases of Clostridium difficile
研究概览
简要总结
Symptoms of Clostridium difficile infection is almost always induced as a complication to the use of antibiotics. Most ICU patients are given antibiotics.
Probiotics has the ability to improve conditions in the gut and it has been shown in some smaller studies that overgrowth of C. difficile can be reduced or prevented.
In this study the intention is to show with sufficient statistical power that a mixture of two otherwise well studied probiotic strains reduces or prevents the incidence of emerging colonisation with C. difficile in critical ill patients on antibiotics.
Half of the patients will be given a mixture of Lactobacillus plantarum 299 and Lactobacillus plantarum 299v twice daily and the rest a placebo mixture.
Rectal swabs or faeces will be analysed for C.difficile and its toxins and the incidence of new cases will be compared for the two groups.
White blood cells (WBC´s), C reactive protein (CRP), lactate, urea, and creatinine will be followed daily as well as antibiotics, corticosteroids and all acid reducing medication.
Nutrition, enteral and total, and bowel habits will be recorded.
详细描述
Infections with Clostridium difficile is considered to be the most frequent health care associated bacterial infection. Almost all cases are connected to the use of antibiotics.
The spectra of symptoms of infection reaches from loose stools to sepsis and death. It is estimated that about 5% of the population are carriers without symptoms.
Elderly people are more likely to be diagnosed with C. difficile infections and as about 50 % of ICU admissions (at least in Sweden) are patients aged 64 years or older C. difficile is also an ICU issue.
Probiotic bacteria given to antibiotic treated patients results in fever cases of infection with C. difficile as we and others have shown in some small studies. Due to a low statistical power in our former study this multicentre study is calculated to be large enough to fulfil statistical requirements.
Adult patients with an expected length of stay in intensive care for three days or more can be included.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anticipated need for intensive care 3 days or longer
- •Patients condition allowing enteral nutrition to be started within 24 h from ICU admission
- •Antibiotics on-going or planned
排除标准
- •Known positive test for Clostridium difficile within the last week
- •Known ulcers in the mouth, oropharynx, esophagus and stomach
- •Known immune deficiencies
- •Enteral nutrition contra indicated
- •Pancreatitis as admission diagnosis at the hospital or at the ICU
- •ICU admission earlier during this period of illness Patient being moribund
研究组 & 干预措施
Probiotics
Patients will be given a mixture of maltodextrin ( a starch product often used i alimentary products) and two strains of probiotic bacteria ( L. plantarum 299 and L. plantarum 299v ) dissolved in water through a nasogastric tube. Patients randomized 1:1 between groups
干预措施: L. plantarum 299 and L. plantarum 299v (+maltodextrin) (Dietary Supplement)
Control
Patients will be given only the dissolved maltodextrin in water through the nasogastric tube. Patients randomized 1:1 between groups
干预措施: Maltodextrin (Other)
结局指标
主要结局
Differences in emerging cases of Clostridium difficile
时间窗: Throughout the ICU stay, expected mean LOS 10 days
Emerging cases of Clostridium difficile, identified as positive cultures and/or toxin tests
次要结局
- White blood cells(Throughout the ICU , expected mean LOS 10 days)
- C Reactive Protein(Throughout the ICU , expected mean LOS 10 days)
- Creatinine(Throughout the ICU , expected mean LOS 10 days)
- Urea(Throughout the ICU , expected mean LOS 10 days)
- Lactate(Throughout the ICU , expected mean LOS 10 days)
- Ventilator days(Throughout the ICU stay, expected mean LOS 10 days)
- Length of stay ICU(Length of ICU stay, about 10 days in accordance with a prior similar study)
- Length of Hospital stay(Within six months from date of ICU admission)
- Survival(Six months)
- Diarrhea and obstipation(Throughout the ICU stay, expected mean LOS 10 days)