Studies of the Human Microbiome in Clinical Center Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- The primary endpoint is to accumulate a sufficiently robust body of intestinal microbiome data and clinical and epidemiological metadata to characterize fully the changes in the human microbiota that occur during the course of hospitalization an...
研究概览
简要总结
Background:
- The intestines, mouth, and skin all contain billions of bacteria and some fungi. Every person s body contains microorganisms like these. They normally do not make people sick. Researchers are interested in how these microorganisms change when a person is hospitalized. They want to find out if changes take place because of the hospitalization (such as treatments used or changes in medical condition) or because of a person s biology (such as their immune system).
Objectives:
- To understand which microorganisms are most likely to spread through hospitals and what affects that spread.
Eligibility:
- People 2 years of age and older who are going to be inpatients at the National Institutes of Health Clinical Center (NIHCC) for at least 48 hours.
Design:
- Clinicians will take samples from participants up to once a day for as long as they are hospitalized at NIHCC.
- Samples will be taken with a swab, from the rectal area, groin, throat, and armpit, and possibly other areas.
- Participants may give a stool sample or be asked to spit into a cup.
- Clinicians will collect some information from participants medical records. They may request some samples of tissue that are left over from procedures already scheduled at NIHCC.
- After participants leave the NIHCC, samples may be taken when they return for follow-up visits from their hospitalization, for up to 2 years. They will not have to return as a follow-up for this study only.
详细描述
The goal of this protocol is to explore changes to microbial communities during the course of hospitalcare, and to determine the extent to which these alterations affect whether hospitalized patients become colonized with healthcare-associated organisms. The study enables collection of clinical specimens and associated medical data to evaluate the natural history, epidemiology, and genomics of patients who might become colonized or infected with a multidrug-resistant organism. Biological specimens including stool, sputum, and swabs will be taken from Clinical Center inpatients at least 2 years of age as frequently as daily through discharge, and at follow-up visits for up to 2 years from the date of enrollment. To understand possible pathogen colonization and infection of hospitalized patients, this protocol will assess the full complement of the microbial-host-environmental contributions including: (1) microbial genome and community;(2) patient s genotype, underlying medical condition, medical treatment; and (3) hospital practices and environment.
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
- 2 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Individuals must meet the following inclusion criteria to participate in the study:
- •Be inpatients in the NIH CC with an expected hospitalization of at least 48 hours beyond the date of referral.
- •Be 2 years of age or older
- •Allow storage of tissue samples for future analyses.
- •Allow genetic testing of body fluids, and tissue specimens.
排除标准
- •A patient will not be eligible if he/she has any condition which, in the investigator s opinion, places the patient at undue risk by participating in the study.
研究组 & 干预措施
Patient
Patients who might become colonized or infected with a multidrug-resistant organism
结局指标
主要结局
The primary endpoint is to accumulate a sufficiently robust body of intestinal microbiome data and clinical and epidemiological metadata to characterize fully the changes in the human microbiota that occur during the course of hospitalization an...
时间窗: At completion of study
Once sufficient microbiome data and clinical and epidemiological meta data is collected we will be able to fully characterize the changes in the human microbiota that occur during the course if hospitalization
次要结局
- Determine the features of microbiota that may render patients vulnerable to or protect patients from colonization with MDROs.(At completion of study)
- Detect the presence of MDROs in biological samples obtained from participants.(At completion of study)
- Determine clinical correlates of MDRO colonization and infection(At completion of study)