Studies of the Human Microbiome in Clinical Center Patients

• Conditions: Multidrug-resistant Colonization

• Registration Number: NCT01933620
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

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.

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 Timeline

• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-09-02
• Study Start: 2014-01-28
• Status Verified: 2025-06-26
• Last Update Submitted: 2025-08-09
• Last Update Posted: 2025-08-12
• Primary Completion: 2028-10-16

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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...	At completion of study	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

Secondary Outcome Measures

Name	Time	Method
Determine the features of microbiota that may render patients vulnerable to or protect patients from colonization with MDROs.	At completion of study
Detect the presence of MDROs in biological samples obtained from participants.	At completion of study
Determine clinical correlates of MDRO colonization and infection	At completion of study

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States