Studies of the Human Microbiome in Clinical Center Patients
Clinical Center
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Abstract
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 nosocomial bacteria. The study enables collection of clinical specimens and associated medical data to evaluate the natural history, epidemiology, and genomics of patients who are expected to be hospitalized for at least seven days. Biological specimens including blood, stool, sputum, and swabs will be taken from CC 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 the dynamics of the fecal and other microbiota of hospitalized patients, this protocol will assess the full complement of the microbial-host-environmental contributions including: (1) microbial genome and community; (2) patients genotype, underlying medical condition, medical treatment; and (3) hospital practices and environment. The protocol has been passed by the IRB and has been engaged with regulatory monitors because it potentially includes pediatric patients. The protocol has enrolled only one adult patient thus far.
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