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Protocol Details

Studies of the Human Microbiome in Clinical Center Patients

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-CC-0180

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 2 Years
Max Age: 120 Years

Referral Letter Required

Yes

Population Exclusion(s)

None

Keywords

Multidrug-Resistant Organism;
Nosocomial Infection;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Multidrug-resistant colonization

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Alison Han, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CRC BG RM 4-2571
10 CENTER DR
BETHESDA MD 20892
(301) 496-2209
alison.han@nih.gov

Alison Han, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CRC BG RM 4-2571
10 CENTER DR
BETHESDA MD 20892
(301) 496-2209
alison.han@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01933620

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