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临床试验/NCT01900119
NCT01900119已完成不适用

A Description of the Oral Microbiome of Patients With Severe Aplastic Anemia

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年12月12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
24
试验地点
1
主要终点
Compare the oral microbiome of SAA patients prior to treatment and after treatment.

研究概览

简要总结

Background:

  • This research is being done to describe the types of bacteria found in the mouths of patients who have severe aplastic anemia (SAA) and are treated with drugs that suppress the immune system or with stem cell transplant. People with SAA who receive these treatments are more likely to get infections. Studies show that there might be a link between the bacteria in your mouth and those bacteria that can cause infections. The bacteria found in the mouths of patients with SAA will be described.

Objectives:

  • To understand the changes in mouth bacteria that are related to treatment and to describe the oral bacterial environment.

Eligibility:

  • Adults at least 18 years of age who are going to be treated for SAA.
  • Healthy volunteers at least 18 years of age.

Design:

  • Participants will answer questions about their medical history and dental care. Their mouths will be examined.
  • Participants with SAA will be tested during treatment for their disease, over the course of 1 year. All participants with SAA will be tested at 3 scheduled appointments. Any participants who require a breathing tube will receive additional tests.
  • Healthy volunteers will be tested during 1 visit.
  • Participants will give two samples each time. A saliva sample will be taken with a disposable padded tool. Skin cells will be collected from the tongue with a small plastic brush.

详细描述

The mouth is a complex biological ecosystem normally containing over 700 different species of bacteria. Some of these bacteria live in an exopolysacchride matrix biofilm and occupy specific niches in this complex oral environment. Understanding the oral environment and the microbiota that inhabit it will assist in determining their impact on health and disease. There are several studies in critically ill patients demonstrating changes in oral bacteria related to acute illness. Identification of respiratory pathogens in the mouth has led researchers to hypothesize that a relationship exists between the oral cavity and pulmonary infections. This descriptive study will characterize the oral microbiota of patients who have severe aplastic anemia (SAA). Patients will be followed for 1 year after treatment for development of respiratory symptoms that require intubation. A difference in the oral microbiome will be identified in specimens collected before and after treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Compare the oral microbiome of SAA patients prior to treatment and after treatment.

时间窗: one year following enrollment

Change in the oral microbiome of patients with SAA. Bacterial data obtained from sequencing

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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