Mucosal Versus Fecal Microbiota in FMT



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2014
End Date:August 2015

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Characterization of the Microbial Genomics of Fecal Bacteriotherapy (FBT): Intestinal Microbiota Transplantation (IMT) for Recurring Clostridium Difficile

Clostridium difficile infection is the most common cause of antibiotic-associated diarrhea.
Treatment of this infection usually occurs using other antibiotics, but many individuals
have persistent diarrhea and multiple relapses. Fecal Transplant (FMT), or Intestinal
Microbiota Transplantation, (IMT) has been shown to be efficacious when administered after
treatment for C. difficile. This study will involve taking biopsies from patients during
their FMT/IMT via colonoscopy, and determine if there are differences in the mucosal flora
as compared to the stool flora. The investigators hope to discover the critical parts of a
healthy microbiota.

A total of 20 subjects with at least one relapse of Clostridium difficile infection
undergoing Intestinal Microbiota Transplantation via colonoscopy will be recruited in this
study. The patients will produce a stool specimen at the time of colonoscopy and a biopsy
will be obtained during the colonoscopy. At 2 weeks and 10 weeks, stool specimens and
anoscopy will be collected to be tested for C. difficile polymerase chain reaction (PCR) and
the fecal microbiota. Subjects will be referred from all locations of Emory Healthcare.

Inclusion Criteria:

- Inpatient or outpatient adults, age ≥18

- Have had at least 1 relapse of C. difficile

- Patients who have had previous FMT

Exclusion Criteria:

- Pregnant or breastfeeding

- Critically or acutely ill (Fever will be defined as a documented temperature >37.8°C)

- Ileus or toxic megacolon

- Unable to give consent
We found this trial at
1
site
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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