Studies of the Human Microbiome in Clinical Center Patients

NCT01933620 | Enrolling By Invitation

• 2 other identifiers: 13018013-CC-0180
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multidrug-resistant Colonization

Keywords

Multidrug-Resistant Organism; Nosocomial Infection; Natural History

Outcome Measures

Primary Outcomes (1)

• 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...

  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

  At completion of study

Secondary Outcomes (3)

• Determine the features of microbiota that may render patients vulnerable to or protect patients from colonization with MDROs.

  At completion of study

• Determine clinical correlates of MDRO colonization and infection

  At completion of study

• Detect the presence of MDROs in biological samples obtained from participants.

  At completion of study

Study Arms (1)

Patient

Patients who might become colonized or infected with a multidrug-resistant organism

Eligibility Criteria

• Age: 2 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals hospitalized at the Clinical Center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alison Han, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 2, 2013
• Study Start: January 28, 2014
• Primary Completion (Estimated): October 16, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-05-20

Locations

US (1)