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临床试验/NCT00273949
NCT00273949Unknown不适用

Lactulose for the Prevention of Nosocomial Infections in Children

Bnai Zion Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年1月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
The incidence of diarrhea

研究概览

简要总结

The purpose of this study is to assess the ability of lactulose, a prebiotic agent, to prevent hospital acquired infection in children

详细描述

Despite the adoption of norms regarding enteric isolation, nosocomial infectious diarrhea is common in children(1;2). Viral pathogens, especially rotavirus are responsible for most of the cases. Depending on population, type of hospital, and standard of care, the reported incidence rate ranges from 8 to 33 episodes per 100 admissions(1). Infants and toddlers are at the highest risk of acquiring nosocomial viral gastroenteritis(1;2).

Probiotic bacteria have been shown to be beneficial in the prevention and treatment of gastrointestinal infections as well as reduction of viral shedding(3;4). A recent study by Szajewska et al. (2) showed a significant reduction of nosocomial infections from 33% to 7% by prophylactic treatment with LGG during the hospital stay. Another study however, did not show any difference(1).

Another approach is to use prebiotic treatment. Prebiotics are defined as non-digestible substances that, when ingested, selectively promote the growth and establishment of beneficial probiotic-like bacteria normally present in the gut(5).

Lactulose is a semi-synthetic disaccharide made from lactose by a chemical reaction which was first described in 1930(6).

In contrast to other prebiotics, lactulose has up to now been mainly used as a medicinal drug for constipation and hepatic encephalopathy(6). In 1957 Petuely published the basic work about lactulose as "the bifidus factor" which was confirmed by MacGillivray et al(6).They found that the composition of the colonic microflora of bottle-fed babies is very much like that of adults while if lactulose is added to the formula milk such babies have the same composition as breast-fed babies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double

入排标准

年龄范围
2 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All children aged 2 to 36 months who are admitted to the hospital for reasons other than diarrhea will be eligible for the study.

排除标准

  • Children with a history of probiotics or prebiotics use within 7 days before admission, acute gastroenteritis within 3 days before admission, vomiting, treated chronic constipation, known anatomic problem in the gastrointestinal tract will be excluded from the study.

结局指标

主要结局

The incidence of diarrhea

次要结局

  • Incidence of rotavirus diarrhea

研究者

申办方类型
Other Gov

研究点 (2)

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