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 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multidrug-resistant Colonization

Detailed Description

The goal of this protocol is to explore changes to microbial communities during the course of hospitalcare, 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 multidrug-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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals hospitalized at the Clinical Center

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patient; Patients who might become colonized or infected with a multidrug-resistant organism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Alison Han, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2014
• Primary Completion (Estimated): October 16, 2028
• Study Completion: October 16, 2025

Study Registration Dates

• First Submitted: August 28, 2013
• First Submitted That Met QC Criteria: August 28, 2013
• First Posted (Estimated): September 2, 2013

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: May 20, 2026

More Information

Terms related to this study

• Keywords: Natural History; Nosocomial Infection; Multidrug-Resistant Organism
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Cross Infection
• Other Study ID Numbers: 130180; 13-CC-0180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No