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临床试验/NCT00760773
NCT00760773终止2 期

Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance: Randomized Controlled Trial and Economic Analysis

The Hospital for Sick Children3 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2009年4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
入组人数
132
试验地点
3
主要终点
Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal.

研究概览

简要总结

The objective of this study is to determine for previously healthy children, who present to an ED with acute gastroenteritis, if the probability of daycare absenteeism is significantly different in those who receive a probiotic agent compared to those who receive placebo.

详细描述

Gastroenteritis in children utilizes significant health care resources and has a significant impact on children, caregivers and society. In the United States, gastroenteritis accounts for more than 1.5 million outpatient visits and 200,000 hospitalizations per year. Data from British Columbia indicate that gastroenteritis annually accounts for 12 million missed workdays by adults and 10 million missed school days by children in this province alone. Canadian data, including the cost of work absenteeism, report the mean annual cost/gastroenteritis case to be $1,089.

Although medications have not routinely been recommended, acute gastroenteritis in children can result in significant morbidity. Thus, physicians and caregivers desire treatment options to reduce the burden of disease. Recently, ondansetron, an antiemetic agent has been found to be effective in pediatric gastroenteritis, and is now frequently employed to reduce vomiting. Probiotics agents may represent another valuable treatment option. Since the early 1990s, research has been conducted on the effects of probiotics, defined as viable microbial preparations that have a beneficial effect on the health and well being of the host.

A recent Cochrane Database systematic review recently concluded that "probiotics appear to be a useful adjunct to rehydration therapy in treating acute, infectious diarrhea." However, the review also concluded that more research is needed to determine which specific probiotic regimens should be employed in specific patient groups. The later statement is of particular importance in North America as probiotics are not a mainstay of clinical practice. While only 18% of Canadian physicians are aware of research on probiotics, 82% feel that more probiotic research is needed, and 76% feel there is a role for probiotics in their practice. This discrepancy likely is due to the absence of probiotic trials in North American patients and because the outcome measures evaluated often have had limited clinical applicability. Since most episodes of acute diarrhea require no specific treatment, cost-effectiveness analyses are also required before the widespread use of probiotics can be endorsed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Months 至 48 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Acute gastroenteritis as determined by the supervising physician.
  • Attend daycare
  • Presence of diarrhea.
  • Duration of vomiting or diarrhea less than 96 hours.
  • Age greater than 90 days
  • Age less than 48 months

排除标准

  • Presence of an indwelling vascular access line or congenital heart disease.
  • Taking immunosuppressive therapy or history of immunodeficiency (including all primary, secondary and acquired states)
  • Have recently had cardiac, oral or gastrointestinal surgery
  • Pancreatic dysfunction or bloody diarrhea
  • History of: hematochezia, underlying chronic gastrointestinal problem, short bowel syndrome or inflammatory bowel disease
  • Family member with an indwelling vascular access line, on immunosuppressive therapy or with a known immunodeficiency
  • Undergoing radiation therapy
  • Exclusively breastfed
  • Bilious or bloody vomitus
  • Previously enrolled in this trial
  • Inability to speak or read English

研究组 & 干预措施

1

Experimental

干预措施: Lacidophil (experimental high dose) (Drug)

2

Experimental

干预措施: Lacidophil (experimental standard dose) (Drug)

3

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal.

时间窗: 2 weeks

次要结局

  • Return visits for unscheduled care to a health care provider related to vomiting, diarrhea, dehydration, fever, or fluid refusal.(2 weeks)
  • Intravenous rehydration(2 weeks)
  • Duration of diarrhea(Meaured by outcome)
  • Duration of vomiting(Meaured by outcome)
  • Number of days the child does not go to daycare.(Measured by outcome)
  • Work absenteeism(2 weeks)
  • Economic analysis(2 weeks)

研究者

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

Stephen Freedman

Adjunct Scientist

The Hospital for Sick Children

研究点 (3)

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