Microbiome Changes in Severe Burns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-07-02

Brief Summary

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The purpose of the study is characterizing changes in the microbiome of severely-injured adult patients as they progress through stages of injury, reconstruction, and recovery from burns.

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Detailed Description

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There exists a vast collection of bacteria that live on, and within, each human body. All surfaces exposed to the external environment, such as the nares, mouth, airway, skin, and intestines, are colonized, and it is estimated that over 100 trillion microbes live within the gastrointestinal tract alone. The interactions between these colonizers and their host have been demonstrated to affect myriad aspects of human health from autism and inflammatory bowel disease to cancer therapy response. Investigations into the role of the intestinal microbiome in sepsis have been ongoing for decades. Data has shown that critically ill patients can not only experience increased intestinal permeability - a factor that allows for the translocation of bacteria and non-microbial tissue injurious factors into the, primarily lymphatic, circulation, but also a disruption of the symbiotic relationship to one of dysbiosis, resulting in what is known as a "pathobiome."

That the microbiome is affected by thermal injury should be no surprise; burn injury has been shown to drive significant intestinal ischemia and inflammation with subsequently increased intestinal permeability. , Burn-induced lung injury has been linked to these changes, and alterations in the microbiome between critically-burned patients (when compared with healthy controls) have been demonstrated, with resultant overgrowth of gram-negative anaerobes. Thus, the microbiome has a clear role in affecting the clinical course of thermally-injured patients.

This is a descriptive case series study examining microbiome changes in two adult patients admitted with severe burn injuries. This will be done by obtaining regular stool samples and analyzing the microbial content, as well as obtaining clinical data on patients including those factors likely to influence the microbial content.

Conditions

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Burns Greater Than 20% BSAB Burns

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Characterizing changes in the microbiome

Analyzing the microbial content from stool samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* sustained greater than or equal to 20% body surface area of the body (BSAB)

Exclusion Criteria

* pre-existing clinical infections
* historical evidence of gastrointestinal disease such as Ulcerative Colitis
* Crohn's disease
* Celiac disease
* historical evidence of gastrointestinal Clostridium difficile infection
* no anti-biotic use for 3 months prior to admission
* AIDS
* immune suppressing medications or metastasized cancer
* peritonitis
* non English-speaking

Minimum Eligible Age

17 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No