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临床试验/NCT00367588
NCT00367588已完成不适用

Low Bacterial Diet in Patients With Cytopenia After Intensive Chemotherapy for Hematological Malignancy: a Study of Efficacy

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Colonization of the gut by aerobic Gram negative rods and yeasts

研究概览

简要总结

The purpose of this prospective, randomized study was to determine the efficacy of low bacterial diet, in comparison to normal hospital diet, with gut colonization by aerobic Gram negative rods and yeasts as primary endpoint. In addition, the occurrence of infections and the total costs of hospital care were documented, in order to identify potential cost savings by the use of either diet.

详细描述

Patients with hematological malignancies who receive intensive chemotherapy usually develop a period of cytopenia, during which there is an increased risk of infection. Mucositis can also develop in these patients, enabling micro-organisms, belonging to the endogenous intestinal flora, to translocate from the intestine to the lymphoid tissue and blood. Therefore, when mucositis and cytopenia develop simultaneously, the risk of infection increases further. In this regard bloodstream infection by Gram negative rods and yeasts are an important cause of serious infections causing considerable morbidity.

In order to reduce the risk of infection several preventive measures have been adopted. Fundamentally, all of these measures were designed to prevent either acquisition of Gram negative rods or fungal pathogens from the environment, or the translocation of these potential pathogens across the mucosal barrier of the gut. These measures include protective (or reverse) isolation, antibiotic prophylaxis with antibiotics which selectively eradicate the aerobic Gram negative rods and yeasts from the gut flora, and finally the use of low-bacterial diets.

In this prospective, randomized study on the efficacy of low bacterial diet, in comparison to normal hospital diet, gut colonization by aerobic Gram negative rods and yeasts, the occurrence of infections and the total costs of hospital care were chosen as study endpoints.

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
None

入排标准

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

入选标准

  • acute leukemia receiving remission induction chemotherapy
  • receiving antibiotic prophylaxis for cytopenia leukocytes lower than 1000/mm3 in peripheral blood)
  • informed consent

排除标准

  • 未提供

结局指标

主要结局

Colonization of the gut by aerobic Gram negative rods and yeasts

次要结局

  • The occurrence of infections
  • The total societal costs

研究者

申办方类型
Other

研究点 (2)

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