Microbiome Changes in Severe Burns (Microbiome)
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|ClinicalTrials.gov Identifier: NCT03130868|
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment|
|Burns Greater Than 20% BSAB Burns||Other: Characterizing changes in the microbiome|
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.
|Study Type :||Observational|
|Estimated Enrollment :||2 participants|
|Official Title:||Microbiome Changes in Severe Burns|
|Actual Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||July 15, 2018|
|Estimated Study Completion Date :||July 15, 2018|
- Other: Characterizing changes in the microbiome
Analyzing the microbial content from stool samples
- microbial diversity of stool samples [ Time Frame: up to 6 months ]We will be analyzing the stool composition at the phyla level, looking at the percentages of the five major phyla - Firmicutes, Bacteroidetes, Proteobacteria, Acitonobacteria, and Fusobacteria
Biospecimen Retention: Samples With DNA
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): NCT03130868
|Contact: Sandi Wewerka, MPHemail@example.com|
|United States, Minnesota|
|Saint Paul, Minnesota, United States, 55101|
|Contact: Sandi Wewerka, MPH 651-254-5304 Sandi.firstname.lastname@example.org|
|Principal Investigator:||William J Mohr, MD||HealthPartners Institute|