Study of the Human Microbiome in Clinical Center Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 4/5/2019 |
| Start Date: | August 28, 2013 |
| End Date: | July 31, 2020 |
| Contact: | Tara N Palmore, M.D. |
| Email: | tpalmore@mail.nih.gov |
| Phone: | (301) 594-6818 |
Studies of the Human Microbiome in Clinical Center Patients
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 over 2 years of age who are going to be inpatients at the National Institutes of
Health Clinical Center (NIHCC) for at least 1 week.
Design:
- Clinicians will take samples from participants up to once a day for as long as they are
hospitalized at NIHCC.
- Blood will be taken from a needle in the arm. This will be done only once, unless the
participant gets a certain infection.
- Swabs will be taken with a cotton 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.
- 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 over 2 years of age who are going to be inpatients at the National Institutes of
Health Clinical Center (NIHCC) for at least 1 week.
Design:
- Clinicians will take samples from participants up to once a day for as long as they are
hospitalized at NIHCC.
participant gets a certain infection.
- Swabs will be taken with a cotton 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.
The goal of this protocol is to explore changes to microbial communities during the course of
hospital care, 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
multi-drug 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.
hospital care, 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
multi-drug 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.
- 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.
EXCLUSION CRITERIA:
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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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