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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 : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

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.

Condition or disease Intervention/treatment
Burns Greater Than 20% BSAB Burns Other: Characterizing changes in the microbiome

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.


Study Type : Observational
Estimated Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources


Intervention Details:
    Other: Characterizing changes in the microbiome
    Analyzing the microbial content from stool samples


Primary Outcome Measures :
  1. 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
fecal samples from patients will be non-invasively collected


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Ages Eligible for Study:   17 Years to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients will be admitted patients at the Regions Hospital Burn Center
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

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): NCT03130868


Contacts
Contact: Sandi Wewerka, MPH 651-254-5304 sandi.s.wewerka@healthpartners.com

Locations
United States, Minnesota
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Sandi Wewerka, MPH    651-254-5304    Sandi.s.wewerka@healthpartners.com   
Sponsors and Collaborators
HealthPartners Institute
Investigators
Principal Investigator: William J Mohr, MD HealthPartners Institute

Publications:

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03130868     History of Changes
Other Study ID Numbers: A16-761
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Burns
Wounds and Injuries