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临床试验/NCT04012788
NCT04012788Unknown不适用

The Effectiveness of a Synbiotic Mixture (Inulin, Lactobacillus Rhamnosus (LGG®), Lactobacillus Acidophilus (LA-5®), Lactobacillus Paracasei, and Bifidobacterium Lactis (BB-12®)), on Decreasing Recurrence of Clostridium Difficile Associated Diarrhea- a , Randomized, Placebo-controlled Study With 4 Weeks Intervention

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Reduced recurrence of C. difficile-associated diarrhoea (CDAD) after 8 weeks

研究概览

简要总结

The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

详细描述

Probiotics have been tested for their efficacy in preventing infection with C. difficile after antibiotic exposure. Some of the most effective probiotics tested Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®). However, most studies have focused on prevention of the first incidence of C. difficile infection rather than prevention of re-infection with C. difficile. Recurrence rates of C. difficile infection (CDI) among hospitalized patients are 15-25% - either as relapses caused by the original organism or re-infection following treatment. The potential of probiotics in preventing re-infection is less studied in these patients. Further, prebiotics which are carbohydrates only metabolized by beneficial bacteria have gained much attention the recent years for their health benefits through stimulating growth of specific types of bacteria in the gut, and recent data from mouse studies show that the prebiotic inulin can eliminate C. difficile growth, but the use of prebiotics in relation to C. difficile elimination has yet to be proven in humans. The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

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)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with primary CDI
  • Treatment with Vancomycin
  • Subjects over 18 years of age
  • Signed informed consent

排除标准

  • Chemotherapy within two months and an absolute neutrophil count of < 1000 neutrophiles/mm3
  • Acute leukemia
  • Serious immunodeficiency
  • Pancreatitis
  • Planned or recent intraabdominal operation within a time window of 14 days
  • Terminal disease with expected survival time < 3 month
  • Probiotic consumption within two weeks prior enrollment
  • Pregnant or lactating women
  • A history of inflammatory or irritable bowel disease
  • Colectomy and cirrhosis
  • Toxic megacolon

研究组 & 干预措施

probiotic arm

Active Comparator

inulin, 15 g Lactobacillus rhamnosus (LGG®) Lactobacillus acidophilus (LA-5®) Lactobacillus paracasei (L. casei 431®) Bifidobacterium lactis (BB-12®), Total cell counts 150 billion/day

干预措施: Synbiotic mixture (Dietary Supplement)

placebo arm

Placebo Comparator

placebo powder, 15 g

干预措施: Placebo comparator (Other)

结局指标

主要结局

Reduced recurrence of C. difficile-associated diarrhoea (CDAD) after 8 weeks

时间窗: 1 year

telephone questionnaire with patient at end of trial as well as examination of each patient's medical record

次要结局

  • toxin A and B levels measured by qPCR(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Munk Petersen

MD, Cosultant, PhD

Hvidovre University Hospital

研究点 (1)

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