Studies of the Human Microbiome in Clinical Center Patients

Conditions

• Multidrug-resistant Colonization

Eligibility Criteria

Sex

ALL

Age

2 Years - 120 Years

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Jan 28, 2014

Status verified

May 2026

Primary completion

Oct 16, 2028

Study Design

Enrollment

250 participants (estimated)

Arms

• Arm: Patient
  Patients who might become colonized or infected with a multidrug-resistant organism

Primary Outcome Measure

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 ]

Locations (1)

Find similar trials in Bethesda, MD