Protocol Details
Studies of the Human Microbiome in Clinical Center Patients
This study is currently recruiting participants.
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.
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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT01933620