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临床试验/NCT02707198
NCT02707198终止2 期

Prevention of Clostridium Difficile-associated Diarrhea by Daily Intake of Kefir

St. Luke's Hospital of Duluth0 个研究点目标入组 2 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
2
主要终点
Incidence of Diarrhea Among the Three Randomized Study Groups Over Time

研究概览

简要总结

This study is being conducted to investigate the potential benefits of probiotic intake for preventing antibiotic associated diarrhea and Clostridium difficile infection in patients undergoing a systemic antibiotic treatment. The primary research question is: can daily intake of kefir, a yogurt-like food containing probiotics, reduce the incidence of diarrhea and Clostridium difficile infection in patients during antibiotic treatment?

详细描述

Background and Significance

Clostridium difficile infections are of great concern for hospitals nationwide and C. difficile remains the most common nosocomial infection in North America. The majority of patients with C. difficile infection respond to orally administered metronidazole or vancomycin, but 5-30% of patients go on to develop recurrent infection and diarrhea, despite antibiotic treatments. The idea that gut microbiota influence susceptibility and recovery from disease is becoming more widely reported. Disruption of normal bacterial flora in the gut during systemic antibiotic use has been attributed to the uncontrolled growth of bacteria that are otherwise suppressed such as C. difficile. Even after an antibiotic regimen has concluded, restoration of the normal gut microbiota is thought to be paramount to interrupting the cycle of C. difficile infection. The idea of reintroducing normal microbial flora to patients with recurrent C. difficile infections has been the foundation upon which the use of probiotic agents, including fecal transplants, has been introduced. The use of probiotics to treat antibiotic-associated diarrhea, and specifically C. difficile infections, has been studied and successes have been reported, and in particular by our group. The emerging idea, however, is that probiotic consumption can be used to prevent the onset of a C. difficile infection, which requires further study. Meta-analyses have been conducted on previously reported data and ultimately conclude that the use of probiotics is safe and effective. However, there remains a need for a focused and controlled study assessing the efficacy of kefir consumption on the incidence of C. difficile infections at St. Luke's Hospital in Duluth, MN, and CHI Creighton University Medical Center in Omaha, NE. The data collected from this study have the potential to change clinical practice at not only our institutions, but at any hospital or institution that has a population of patients undergoing systemic antibiotic treatment.

Risk factors for persistent C. difficile infection include age greater than 65 years, poor nutritional status, recent abdominal surgery, prolonged hospitalization and recent stay in the ICU. The purpose of this study is to determine if administering a daily regimen of kefir to at-risk patients can reduce the incidence of C. difficile infections. Because treatment for C. difficile infections is difficult and expensive, and recurrent infections are common, a way to prevent these infections is of great interest. A preventive measure that reduces the incidence of diarrhea and C. difficile infections will clearly improve patient health, and will have a multi-fold impact on how patients are cared for while in the hospital as well as post-discharge. There is potential for cost-saving, as well, in the form of the direct cost of antibiotic treatments and prolonged hospital stays. Additionally, the cost in time and effort to prevent the spread of these infections will be reduced, as well, all of which ultimately improve patient care.

Preliminary Studies

Many studies have been published indicating a potential for probiotics as a prophylaxis against diarrhea associated with antibiotic use in humans. Additionally, a recent report in a rodent model suggests that kefir consumption concomitantly with antibiotic treatment may prevent the development of C. difficile-associated diarrhea. However, to our knowledge there have not been any studies published that have investigated the preventive effects of kefir consumption specifically related C. difficile infection in human patients. This protocol will serve as an initial study for a subset of at-risk patients and the data collected will provide guidance for future studies to include a more broad range of at-risk patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have:
  • Been admitted to the medical unit on 7 West at St. Luke's Hospital (Duluth, MN)
  • Been prescribed a systemic antibiotic of any kind (administered by oral or parenteral route), but have not yet started the regimen
  • Consented to be randomized and take part in the study and are adults greater than 19 years of age

排除标准

  • Patients who are/have:
  • Tube feeding
  • Undergoing dialysis and other renal treatment
  • An existing C. difficile infection
  • A recent history of C. difficile infection (within the last 3 months)
  • A recent history of antibiotic use (within the last 3 months)
  • Inflammatory bowel disease, Crohn's disease, or other chronic gastrointestinal syndrome
  • A history of acquired of genetic immunodeficiencies; active, acute or chronic serious infections (i.e., viral hepatitis, HIV/AIDS), or autoimmune disorders
  • Undergoing gastrointestinal surgery, radiation, or cytotoxic chemotherapy
  • Allergy to milk protein

研究组 & 干预措施

Group B

Active Comparator

Will receive prescribed antibiotics and will receive kefir only during hospital stay. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.

干预措施: kefir (Drug)

Group C

Active Comparator

Will receive prescribed antibiotics and will receive kefir during hospital stay and for the duration of the prescribed antibiotic regimen for up to a total of 30 days . Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.

干预措施: kefir (Drug)

结局指标

主要结局

Incidence of Diarrhea Among the Three Randomized Study Groups Over Time

时间窗: Assessed daily during hospitalization and daily for up to 30 days post-discharge; data will be represented as an overall incidence of diarrhea for all compliant patients upon study completion (average tracking time per patient is 35 days).

The overall incidence of diarrhea, represented as a percentage of patients, that develop diarrhea during the course of their enrollment in the study (an average of 35 days).

次要结局

  • Incidence of Clostridium Difficile Infection Among the Three Randomized Study Groups Over Time(Assessed at any point during a patient's enrollment in the study (average of 35 days) when clinical symptoms require a C. difficile test per standard of care. Individual patients are tracked for an average of 35 days; data reported at study completion)

研究者

发起方
St. Luke's Hospital of Duluth
申办方类型
Other
责任方
Sponsor

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