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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
Sponsor:
Information provided by (Responsible Party):
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 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.

Design:

- 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
Multidrug-Resistant Organism

Detailed Description:
The goal of this protocol is to explore changes to microbial communities during the course of hospital care, 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 multi-drug 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.

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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



Primary Outcome Measures :
  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... [ Time Frame: At completion of study ]

Secondary Outcome Measures :
  1. Detect the presence of MDROs in biological samples obtained fromparticipants [ Time Frame: At completion of study ]
  2. Determine the features of microbiota that may render patients vulnerable to or protect patients from colonization with MDROs [ Time Frame: At completion of study ]
  3. Determine immune and clinical correlates of MDRO colonizationand infection. [ Time Frame: At completion of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals hospitalized at the Clinical Center
Criteria
  • 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.


Information from the National Library of Medicine

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


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Tara N Palmore, M.D. National Institutes of Health Clinical Center (CC)

Additional Information:
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01933620     History of Changes
Other Study ID Numbers: 130180
13-CC-0180
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: April 17, 2019
Keywords provided by National Institutes of Health Clinical Center (CC):
Multidrug-Resistant Organism
Nosocomial Infection