Study of the Human Microbiome in Clinical Center Patients
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|ClinicalTrials.gov Identifier: NCT01933620|
Recruitment Status : Enrolling by invitation
First Posted : September 2, 2013
Last Update Posted : October 22, 2019
- 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).
- To understand which microorganisms are most likely to spread through hospitals and what affects that spread.
- 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.
- Clinicians will take samples from participants up to once a day for as long as they are hospitalized at NIHCC.
<TAB>- 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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||Studies of the Human Microbiome in Clinical Center Patients|
|Actual Study Start Date :||January 28, 2014|
|Estimated Primary Completion Date :||July 31, 2030|
|Estimated Study Completion Date :||January 1, 2031|
Patients who might become colonized or infected with a multi drug-resistant organism
- 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... [ Time Frame: At completion of study ]
- Detect the presence of MDROs in biological samples obtained fromparticipants [ Time Frame: At completion of study ]
- Determine the features of microbiota that may render patients vulnerable to or protect patients from colonization with MDROs [ Time Frame: At completion of study ]
- Determine immune and clinical correlates of MDRO colonizationand infection. [ Time Frame: At completion of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933620
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Tara N Palmore, M.D.||National Institutes of Health Clinical Center (CC)|