Clinical trial NCT03130868: Microbiome Changes in Severe Burns
Official title: Microbiome Changes in Severe Burns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns Greater Than 20% BSAB
Burns
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 2
Sex: ALL
Minimum age (years): 17
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be admitted patients at the Regions Hospital Burn Center

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: microbial diversity of stool samples
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: William J Mohr, MD
role: PRINCIPAL_INVESTIGATOR
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